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CompletedNCT00265850Updated Aug 7, 2026Results posted

Cetuximab and/or Bevacizumab Combined With Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

A Phase 3 interventional study of bevacizumab and cetuximab in Colorectal Cancer, sponsored by Alliance for Clinical Trials in Oncology. Completed at 683 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by Alliance for Clinical Trials in Oncology · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
2,334
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

PURPOSE: This randomized phase III trial is studying cetuximab and/or bevacizumab when given together with combination chemotherapy to compare how well they work in treating patients with metastatic colorectal cancer.

RATIONALE: Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as fluorouracil, leucovorin, oxaliplatin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibodies together with combination chemotherapy may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective with cetuximab and/or bevacizumab in treating patients with colorectal cancer.

Read the detailed description

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to physician-selected chemotherapy (FOLFOX or FOLFIRI), prior adjuvant chemotherapy (yes vs no), and prior pelvic radiotherapy (yes vs no). Patients were randomized to 1 of 3 treatment arms.

Primary Objective:

  • To determine if the addition of cetuximab to FOLFIRI or FOLFOX chemotherapy prolongs survival compared to FOLFIRI or FOLFOX with bevacizumab in patients with untreated, advanced or metastatic colorectal cancer who have K-ras wild type tumors.

Secondary Objectives:

  • To evaluate response, progression-free survival (PFS), time to treatment failure (TTF), and duration of response (DR) among patients with unresectable advanced metastatic colon cancer treated with bevacizumab or cetuximab in addition to chemotherapy with FOLFIRI or FOLFOX
  • To evaluate toxicity and, in particular, 60-day mortality among patients with unresectable advanced metastatic colon cancer treated with bevacizumab or cetuximab in addition to chemotherapy with FOLFIRI or FOLFOX
  • To describe patients with unresectable locally advanced or metastatic colorectal cancer rendered "resectable" with chemotherapy

There are premedication guidelines that were established for patients assigned to receive cetuximab. All patients must be premedicated with diphenhydramine hydrochloride 50 mg (or a similar agent) IV prior to the first dose of cetuximab in an effort to prevent an infusion or hypersensitivity reaction. Premedication is also recommended prior to subsequent doses, but at the investigator's discretion the dose of diphenhydramine (or a similar agent) may be reduced. Pretreatment with acetaminophen may also be used.

There are bevacizumab administration instructions for patients for whom surgery is being contemplated or required. For patients for whom elective surgery is contemplated, bevacizumab is to be discontinued for at least 8 weeks prior to surgery. Bevacizumab may be resumed after at least 4 weeks following surgery. Patients who undergo complete resection of metastatic disease will discontinue protocol therapy and may receive further treatment at the treating physician's discretion. For patients for whom non-elective surgery is required, hold bevacizumab as long as possible prior to surgery and for at least 6 weeks following surgery.

Patients received a minimum of two cycles of therapy. Patients were allowed to receive ancillary therapy per protocol. Treatment continued until disease progression, unacceptable toxicity, or surgery with curative intent as planned. After completion of study treatment, patients are followed up to 5 years.

02

Conditions studied

  • Colorectal Cancer

Keywords

  • recurrent colon cancer
  • stage III colon cancer
  • stage III rectal cancer
  • stage IV colon cancer
  • recurrent rectal cancer
  • stage IV rectal cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 2,334 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

  1. Locally Advanced or Metastatic Colorectal Cancer

    1. Eligible patients must have histologically or cytologically documented adenocarcinoma of the colon or rectum. Patients must have either locally advanced (unresectable) or metastatic disease. Patients with resected primary tumors who have documented metastases are eligible. Documentation of residual disease by CT scan or surgeon's notes is required for all patients, and histologic confirmation of metastases is strongly encouraged.

    2. Patients with a history of colorectal cancer treatment by surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless:

      • Either an interval of greater than five years has elapsed between the primary surgery and the development of metastatic disease or
      • The primary cancer was stage I. Clinicians should consider biopsy of lesions to establish the diagnosis of metastatic colorectal cancer in each case if there is substantial clinical ambiguity regarding the nature or source of apparent metastases.
    3. At the time of randomization, the intent of this treatment must be indicated palliative or neoadjuvant chemotherapy with the potential for resection of all sites of metastatic disease.
  2. Only patients with a wildtype K-ras gene as determined by the laboratory at the SWOG Solid Tumor Repository or by a local CLIA-certified laboratory are eligible. Patients with a mutation in the K-ras gene are ineligible. All patients must have available for analysis of K-ras status at least one H and E slide and one paraffin block of the previously resected primary colorectal tumor and/or a tumor deposit. For patients registered and randomized based on local CLIA-certified laboratory results, SWOG analysis will be confirmatory only.

  3. Prior Treatment

    1. No prior systemic treatment for advanced or metastatic colorectal cancer is allowed. Prior regional chemotherapy (eg, hepatic arterial infusion) is also not allowed.

      • Patients may have received prior adjuvant chemotherapy that included fluorouracil alone or in combination with fluorouracil and oxaliplatin or irinotecan (no more than 6 months); or radiation with radiosensitizing chemotherapy.
      • The last course of adjuvant chemotherapy must have concluded > 12 months prior to colorectal cancer recurrence.
      • Patients may have received neoadjuvant chemo-radiation with capecitabine or 5-fluorouracil.
      • Patients may not have received itraconazole or ketoconazole less than 4 weeks prior to randomization.
      • No prior exposure to any tyrosine kinase inhibitors or other agents (including protein products, monoclonal antibodies, antisense, etc.) that target VEGF or EGF receptors is allowed.
      • No prior treatment with bevacizumab or cetuximab.

    2. Patients may not have had prior radiotherapy to greater than 25% of bone marrow.

      (Standard adjuvant rectal cancer chemoradiation will not exclude patient from protocol entry.) Radiation must have concluded ≥ 4 weeks prior to randomization.

    3. Patients should have completed any major surgery ≥ 4 weeks from randomization. Patients must have completed any minor surgery ≥ 2 weeks prior to randomization. Patients must have fully recovered from the procedure. (Insertion of a vascular access device is not considered major or minor surgery.)
  4. No previous or concurrent malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for five years.

  5. For patients who are to receive FOLFIRI: No evidence of Gilbert's Syndrome or of homozygosity for the UGT1A1*28 allele.

    1. Patients with Gilbert's Syndrome may have a greater risk of irinotecan toxicity due to the abnormal glucuronidation of SN-38. Evidence of Gilbert's Syndrome would include a prior finding of an isolated elevation of indirect bilirubin.
    2. UGT1A1 genotyping is not required on this study. However, patients known to be homozygous for the UGT1A1*28 allele are not to receive FOLFIRI for this study. Patients with Gilbert's Syndrome or who are found to be homozygous for the UGT1A1 allele who will receive FOLFOX are eligible.
  6. No sensory peripheral neuropathy of ≥ grade 2 at baseline for patients who are to receive FOLFOX.
  7. No known central nervous system metastases or carcinomatous meningitis.
  8. No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung.
  9. No pleural effusion or ascites that causes ≥ grade 2 dyspnea.
  10. No predisposing colonic or small bowel disorders in which the symptoms are uncontrolled as indicated by baseline pattern of > 3 watery or soft stools daily in patients without a colostomy or ileostomy. Patients with a colostomy or ileostomy may entered at investigator discretion.
  11. Patients must not have an uncontrolled seizure disorder, or active neurological disease.
  12. No current congestive heart failure (New York Heart Association Class II, III or IV)
  13. Patients with history of hypertension must be well controlled ( \< 160/90) on a regimen of anti-hypertensive therapy.

  14. Patients on full-dose anticoagulation (eg, warfarin) are eligible provided that both of the following criteria are met:

    1. The patient has an in-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or be on a stable dose of low molecular weight heparin.
    2. The patient has no active bleeding or pathological condition that carries a high risk of bleeding (eg, tumor involving major vessels or known varices).
  15. Patients receiving anti-platelet agents are eligible. In addition, patients who are on daily prophylactic aspirin or anticoagulation for atrial fibrillation are eligible.

  16. No significant history of bleeding events or GI perforation:

    1. Patients with a history of significant bleeding episodes (eg, hemoptysis, upper or lower GI bleeding ) within 6 months of randomization are not eligible unless the source of bleeding has been resected.
    2. Patients with a history of GI perforation within 12 months of randomization are not eligible.
  17. No arterial thrombotic events within 6 months before randomization, including transient ischemic attack (TIA), cerebrovascular accident (CVA), unstable angina or angina requiring surgical or medical intervention in the past 6 months, or myocardial infarction (MI). Patients with clinically significantly peripheral artery disease (eg, claudication on less than one block) or any other arterial thrombotic event are also ineligible.
  18. No serious or non-healing wound, ulcer or bone fracture
  19. Patients with known hypersensitivity to Chinese hamster ovary cell products or to recombinant human or murine antibodies are not eligible.

  20. Non-pregnant and not nursing:

    1. Women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to randomization.
    2. DNA alkylating agents are known to be teratogenic, and the effects of irinotecan, oxaliplatin, 5-FU, bevacizumab, and cetuximab on a developing fetus at the recommended therapeutic doses are unknown.
    3. Women of child-bearing potential include any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal.
    4. Postmenopausal is defined as amenorrhea ≥ 12 consecutive months or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL.
    5. Women of child-bearing potential also include women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (eg, vasectomy), should be considered to be of child bearing potential.
  21. ECOG Performance Status of 0-1
  22. Age ≥ 18 years

  23. Required Initial Laboratory Values:

    1. Granulocytes ≥ 1500 µL
    2. Hemoglobin ≥ 9.0 grams/dL (patient may be transfused to meet this criterion)
    3. Platelet count ≥ 100,000/µL
    4. Creatinine ≤ 1.5 x Upper limits of normal
    5. Bilirubin ≤ 1.5 mg/dL
    6. Albumin ≥ 2.5 g/dL

    7. Urinalysis ≤ 1 + protein*

      • *Patients discovered to have ≥ 2+ proteinuria at baseline must undergo a 24-hour urine collection that must demonstrate \< 1 g of protein/24 hour or have a UPC \< 1.0 to allow participation in the study.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,334 participants (actual)

Study arms

  • Active comparator
    Arm A: FOLFOX or FOLFIRI + bevacizumab

    Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.

    Biological: bevacizumab · Drug: FOLFOX or · Drug: FOLFIRI

  • Experimental
    Arm B: FOLFOX or FOLFIRI + cetuximab

    Patients receive cetuximab 400mg/m\^2 IV over 2 hours on the first day of treatment, then 250 mg/m\^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.

    Biological: cetuximab · Drug: FOLFOX or · Drug: FOLFIRI

  • Experimental
    Arm C: FOLFOX or FOLFIRI + cetuximab + bevacizumab

    Patients receive cetuximab 400mg/m\^2 IV over 2 hours on the first day of treatment, then 250 mg/m\^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.

    Biological: bevacizumab · Biological: cetuximab · Drug: FOLFOX or · Drug: FOLFIRI

Interventions

  • Biologicalbevacizumab

    Given IV

  • Biologicalcetuximab

    Given IV

  • DrugFOLFOX or

    Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours

    Also known as: Eloxatin (oxaliplatin), leucovorin (folinic acid) and 5-Fluorouracil (5-FU)

  • DrugFOLFIRI

    Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours.

    Also known as: CPT-11 (irinotecan), leucovorin (folinic acid), and 5-Fluorouracil (5-FU)

06

What researchers measure

Primary outcomes

  1. Overall Survival

    Survival time will be defined as the time from registration to death. Time to event distributions will be estimated using the Kaplan-Meier method. Overall Survival (OS) will be compared between Arm A and Arm B.

    Time frame: Up to 5 years post-treatment

Secondary outcomes

  1. Progression-free Survival (PFS)

    PFS will be measured from study entry until first documented progression or death from any cause. Time to event distributions will be estimated using the Kaplan-Meier method. PFS will be compared between Arm A and Arm B.

    Time frame: Up to 5 years post-treatment

  2. Time to Treatment Failure

    Time frame: Up to 5 years post-treatment

  3. Duration of Tumor Response

    Time frame: Up to 5 years post-treatment

07

Results

Posted Apr 26, 2017

Participant flow

Participant flow — Overall Study
MilestoneArm A: FOLFOX or FOLFIRI + BevacizumabArm B: FOLFOX or FOLFIRI + CetuximabArm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab
Started899902533
Completed899902533
Not completed000

Outcome measures

PrimaryOverall Survival

Survival time will be defined as the time from registration to death. Time to event distributions will be estimated using the Kaplan-Meier method. Overall Survival (OS) will be compared between Arm A and Arm B.

Time frame:
Up to 5 years post-treatment
Reported as:
Median · months
Overall Survival
monthsArm A: FOLFOX or FOLFIRI + BevacizumabArm B: FOLFOX or FOLFIRI + CetuximabArm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab
Overall Survival29.0 (25.6 to 31.2)30.0 (27.5 to 32.8)—
Statistical analysis
  • Arm A: FOLFOX or FOLFIRI + Bevacizumab vs Arm B: FOLFOX or FOLFIRI + Cetuximab · Log Rank · p = 0.08 · Hazard ratio (hr): 0.88 · 95% CI 0.77 to 1.01
SecondaryProgression-free Survival (PFS)

PFS will be measured from study entry until first documented progression or death from any cause. Time to event distributions will be estimated using the Kaplan-Meier method. PFS will be compared between Arm A and Arm B.

Time frame:
Up to 5 years post-treatment
Reported as:
Median · months
Progression-free Survival (PFS)
monthsArm A: FOLFOX or FOLFIRI + BevacizumabArm B: FOLFOX or FOLFIRI + CetuximabArm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab
Progression-free Survival (PFS)10.6 (9.5 to 11.1)10.5 (9.5 to 11.3)—
Statistical analysis
  • Arm A: FOLFOX or FOLFIRI + Bevacizumab vs Arm B: FOLFOX or FOLFIRI + Cetuximab · Log Rank · p = 0.45 · Hazard ratio (hr): 0.95 · 95% CI 0.84 to 1.08
SecondaryTime to Treatment Failure
Time frame:
Up to 5 years post-treatment
Reported as:
Median · months
Time to Treatment Failure
monthsArm A: FOLFOX or FOLFIRI + BevacizumabArm B: FOLFOX or FOLFIRI + Cetuximab
Time to Treatment Failure5.3 (5.1 to 5.6)5.5 (5.1 to 5.7)
Statistical analysis
  • Arm A: FOLFOX or FOLFIRI + Bevacizumab vs Arm B: FOLFOX or FOLFIRI + Cetuximab · Log Rank · p = 0.44 · Hazard ratio (hr): 0.96 · 95% CI 0.85 to 1.07
SecondaryDuration of Tumor Response
Time frame:
Up to 5 years post-treatment
Reported as:
Median · months
Duration of Tumor Response
monthsArm A: FOLFOX or FOLFIRI + BevacizumabArm B: FOLFOX or FOLFIRI + Cetuximab
Duration of Tumor Response10.0 (9.2 to 11.3)10.6 (9.5 to 12.3)
Statistical analysis
  • Arm A: FOLFOX or FOLFIRI + Bevacizumab vs Arm B: FOLFOX or FOLFIRI + Cetuximab · Log Rank · p = 0.30 · Hazard ratio (hr): 0.92 · 95% CI 0.79 to 1.08

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm A: FOLFOX or FOLFIRI + Bevacizumab—98/559 (17.5%)531/559 (95%)
Arm B: FOLFOX or FOLFIRI + Cetuximab—111/578 (19.2%)548/578 (94.8%)
Most frequent serious events
Showing 10 of 81
Most frequent serious events
EventArm A: FOLFOX or FOLFIRI + BevacizumabArm B: FOLFOX or FOLFIRI + Cetuximab
Neutrophil count decreasedInvestigations35/55936/578
ThrombosisVascular disorders14/55922/578
Vascular access complicationInjury, poisoning and procedural complications2/5597/578
Death NOSGeneral disorders and administration site conditions5/5592/578
Serum magnesium decreasedMetabolism and nutrition disorders0/5595/578
FatigueGeneral disorders and administration site conditions4/5593/578
SepsisInfections and infestations0/5594/578
Blood glucose increasedMetabolism and nutrition disorders1/5594/578
Respiratory disorderRespiratory, thoracic and mediastinal disorders0/5594/578
Myocardial ischemiaCardiac disorders3/5591/578
Most frequent other events
Showing 10 of 373
Most frequent other events
EventArm A: FOLFOX or FOLFIRI + BevacizumabArm B: FOLFOX or FOLFIRI + Cetuximab
FatigueGeneral disorders and administration site conditions397/559418/578
Peripheral sensory neuropathyNervous system disorders355/559344/578
DiarrheaGastrointestinal disorders304/559346/578
Neutrophil count decreasedInvestigations316/559334/578
Serum magnesium decreasedMetabolism and nutrition disorders56/559231/578
Platelet count decreasedInvestigations208/559210/578
Abdominal painGastrointestinal disorders189/559186/578
HypertensionVascular disorders179/55980/578
VomitingGastrointestinal disorders174/559185/578
ProteinuriaRenal and urinary disorders159/55943/578

Baseline characteristics

During the trial, it was learned that KRAS mutation predicted for lack of efficacy of EGFR antibodies; also studies showed no benefit from chemo combined with both Bevacizumab and an EGFR antibody. The trial was amended to 2 arms limited to KRAS wild type patients. Only confirmed and consented KRAS wild type patients were analyzed.

Age, Continuous
Age, Continuous(years)Arm A: FOLFOX or FOLFIRI + BevacizumabArm B: FOLFOX or FOLFIRI + CetuximabArm C: FOLFOX or FOLFIRI + Cetuximab + BevacizumabTotal
Median59 (21.8 to 85)59.2 (20.8 to 89.5)—59.1 (20.8 to 89.5)
Sex: Female, Male
Sex: Female, Male(Participants)Arm A: FOLFOX or FOLFIRI + BevacizumabArm B: FOLFOX or FOLFIRI + CetuximabArm C: FOLFOX or FOLFIRI + Cetuximab + BevacizumabTotal
Female211229—440
Male348349—697
Region of Enrollment
Region of Enrollment(participants)Arm A: FOLFOX or FOLFIRI + BevacizumabArm B: FOLFOX or FOLFIRI + CetuximabArm C: FOLFOX or FOLFIRI + Cetuximab + BevacizumabTotal
Canada3232—64
United States527546—1073
08

Study locations

683 sites
  • Providence Cancer Center at Providence Hospital
    Mobile, Alabama 36608, United States
  • Alaska Regional Hospital Cancer Center
    Anchorage, Alaska 99508, United States
  • Providence Cancer Center
    Anchorage, Alaska 99508, United States
  • Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
    Fort Smith, Arkansas 72903, United States
  • NEA Medical Center - Stadium Boulevard
    Jonesboro, Arkansas 72401, United States
  • Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
    Burbank, California 91505, United States
  • East Bay Radiation Oncology Center
    Castro Valley, California 94546, United States
  • Valley Medical Oncology Consultants - Castro Valley
    Castro Valley, California 94546, United States
  • North Bay Cancer Center
    Fairfield, California 94533, United States
  • Kaiser Permanente - Fremont
    Fremont, California 94538, United States
  • Valley Medical Oncology
    Fremont, California 94538, United States
  • Glendale Memorial Hospital Comprehensive Cancer Center
    Glendale, California 91204, United States
  • California Cancer Care, Incorporated - Greenbrae
    Greenbrae, California 94904, United States
  • Kaiser Permanente Medical Center - Hayward
    Hayward, California 94545, United States
  • Veterans Affairs Medical Center - Loma Linda (Pettis)
    Loma Linda, California 92357, United States
  • USC/Norris Comprehensive Cancer Center and Hospital
    Los Angeles, California 90089-9181, United States
  • Contra Costa Regional Medical Center
    Martinez, California 94553-3156, United States
  • Tibotec Therapeutics - Division of Ortho Biotech Products, LP
    Marysville, California 95901, United States
  • Camino Medical Group - Treatment Center
    Mountain View, California 94040, United States
  • El Camino Hospital Cancer Center
    Mountain View, California 94040, United States
  • Alta Bates Summit Medical Center - Summit Campus
    Oakland, California 94609, United States
  • Bay Area Breast Surgeons, Incorporated
    Oakland, California 94609, United States
  • CCOP - Bay Area Tumor Institute
    Oakland, California 94609, United States
  • Larry G Strieff MD Medical Corporation
    Oakland, California 94609, United States
  • Tom K Lee, Incorporated
    Oakland, California 94609, United States
  • Kaiser Permanente Medical Center - Oakland
    Oakland, California 94611, United States
  • St. Joseph Hospital Regional Cancer Center - Orange
    Orange, California 92868, United States
  • Desert Regional Medical Center Comprehensive Cancer Center
    Palm Springs, California 92262, United States
  • Palo Alto Medical Foundation
    Palo Alto, California 94301, United States
  • Valley Medical Oncology Consultants - Pleasanton
    Pleasanton, California 94588, United States
  • Kaiser Permanente Medical Center - Redwood City
    Redwood City, California 94063, United States
  • Kaiser Permanente Medical Center - Richmond
    Richmond, California 94801, United States
  • Kaiser Permanente Medical Center - Roseville
    Roseville, California 95661, United States
  • University of California Davis Cancer Center
    Sacramento, California 95817, United States
  • South Sacramento Kaiser-Permanente Medical Center
    Sacramento, California 95823, United States
  • Kaiser Permanente Medical Center - Sacramento
    Sacramento, California 95825, United States
  • Kaiser Permanente Medical Office -Vandever Medical Office
    San Diego, California 92108, United States
  • Naval Medical Center - San Diego
    San Diego, California 92134, United States
  • San Francisco General Hospital Medical Center
    San Francisco, California 94110, United States
  • Kaiser Permanente Medical Center - San Francisco Geary Campus
    San Francisco, California 94115, United States
  • UCSF Helen Diller Family Comprehensive Cancer Center
    San Francisco, California 94115, United States
  • Kaiser Permanente Medical Center - Santa Teresa
    San Jose, California 95119, United States
  • Kaiser Foundation Hospital - San Rafael
    San Rafael, California 94903, United States
  • Kaiser Permanente Medical Center - Santa Clara Kiely Campus
    Santa Clara, California 95051, United States
  • Kaiser Permanente Medical Center - Santa Rosa
    Santa Rosa, California 95403, United States
  • Kaiser Permanente Medical Center - South San Francisco
    South San Francisco, California 94080, United States
  • Saint Helena Hospital
    St. Helena, California 94574, United States
  • Kaiser Permanente Medical Facility - Stockton
    Stockton, California 95210, United States
  • Tahoe Forest Cancer Center
    Truckee, California 96161, United States
  • Kaiser Permanente Medical Center - Vallejo
    Vallejo, California 94589, United States
  • Kaiser Permanente Medical Center - Walnut Creek
    Walnut Creek, California 94596, United States
  • San Luis Valley Regional Medical Center
    Alamosa, Colorado 81101, United States
  • Aurora Presbyterian Hospital
    Aurora, Colorado 80012, United States
  • University of Colorado Cancer Center at UC Health Sciences Center
    Aurora, Colorado 80045, United States
  • Boulder Community Hospital
    Boulder, Colorado 80301-9019, United States
  • Memorial Hospital Cancer Center - Colorado Springs
    Colorado Springs, Colorado 80909, United States
  • Penrose Cancer Center at Penrose Hospital
    Colorado Springs, Colorado 80933, United States
  • Denver Health Medical Center
    Denver, Colorado 80204, United States
  • St. Anthony Central Hospital
    Denver, Colorado 80204, United States
  • Kaiser Permanente - Denver
    Denver, Colorado 80205, United States
  • Porter Adventist Hospital
    Denver, Colorado 80210, United States
  • Presbyterian - St. Luke's Medical Center
    Denver, Colorado 80218, United States
  • St. Joseph Hospital
    Denver, Colorado 80218, United States
  • Rose Medical Center
    Denver, Colorado 80220, United States
  • Veterans Affairs Medical Center - Denver
    Denver, Colorado 80220, United States
  • CCOP - Colorado Cancer Research Program
    Denver, Colorado 80224-2522, United States
  • Shaw Regional Cancer Center
    Edwards, Colorado 81632, United States
  • Swedish Medical Center
    Englewood, Colorado 80110, United States
  • Poudre Valley Hospital
    Fort Collins, Colorado 80524, United States
  • Front Range Cancer Specialists
    Fort Collins, Colorado 80528, United States
  • Valley View Hospital Cancer Center
    Glenwood Springs, Colorado 81601, United States
  • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
    Grand Junction, Colorado 81502, United States
  • North Colorado Medical Center
    Greeley, Colorado 80631, United States
  • Kaiser Permanente - Lafayette
    Lafayette, Colorado 80026, United States
  • Littleton Adventist Hospital
    Littleton, Colorado 80122, United States
  • Sky Ridge Medical Center
    Lone Tree, Colorado 80124, United States
  • Hope Cancer Care Center at Longmont United Hospital
    Longmont, Colorado 80501, United States
  • McKee Medical Center
    Loveland, Colorado 80539, United States
  • Montrose Memorial Hospital Cancer Center
    Montrose, Colorado 81401, United States
  • Parker Adventist Hospital
    Parker, Colorado 80138, United States
  • St. Mary - Corwin Regional Medical Center
    Pueblo, Colorado 81004, United States
  • North Suburban Medical Center
    Thornton, Colorado 80229, United States
  • Exempla Lutheran Medical Center
    Wheat Ridge, Colorado 80033, United States
  • Bendheim Cancer Center at Greenwich Hospital
    Greenwich, Connecticut 06830, United States
  • Helen and Harry Gray Cancer Center at Hartford Hospital
    Hartford, Connecticut 06102-5037, United States
  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
    Hartford, Connecticut 06105, United States
  • Middlesex Hospital Cancer Center
    Middletown, Connecticut 06457, United States
  • George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
    New Britain, Connecticut 06050, United States
  • Eastern Connecticut Hematology and Oncology Associates
    Norwich, Connecticut 06360, United States
  • Kent General Hospital
    Dover, Delaware 19901, United States
  • Tunnell Cancer Center at Beebe Medical Center
    Lewes, Delaware 19958, United States
  • CCOP - Christiana Care Health Services
    Newark, Delaware 19713, United States
  • Washington Cancer Institute at Washington Hospital Center
    Washington D.C., District of Columbia 20010, United States
  • Sibley Memorial Hospital
    Washington D.C., District of Columbia 20016, United States
  • Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
    Boca Raton, Florida 33486, United States
  • Memorial Cancer Institute at Memorial Regional Hospital
    Hollywood, Florida 33021, United States
  • Lakeland Regional Cancer Center at Lakeland Regional Medical Center
    Lakeland, Florida 33805, United States
  • Florida Hospital Cancer Institute at Florida Hospital Orlando
    Orlando, Florida 32803-1273, United States
  • Sacred Heart Cancer Center at Sacred Heart Hospital
    Pensacola, Florida 32504, United States
  • Sacred Heart Medical Oncology
    Pensacola, Florida 32514, United States

Showing the first 100 of 683 sites across 2 countries.

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References and documents

Publications

  • Schrag D, Naughton M, Kesselheim A, et al.: Clinical trial participants' strategies for coping with prescription drug costs: A companion study to CALGB 80405. [Abstract] J Clin Oncol 27 (Suppl 15): A-9503, 2009.
  • Venook AP, Blanke CD, Niedzwiecki D, Lenz HJ, Taylor JR, Hollis DR, Sutherland S, Goldberg RM. Revisiting the Cancer and Leukemia Group B/Southwest Oncology Group 80405 Trial: a phase III trial of chemotherapy and biologic agents for patients with untreated advanced colorectal adenocarcinoma. Clin Colorectal Cancer. 2007 May;6(7):536-8. doi: 10.3816/CCC.2007.n.021. No abstract available. PubMed 17553204 ↗
  • Venook AP, Blanke CD, Niedzwiecki D, Lenz HJ, Taylor JR, Hollis DR, Sutherland S, Goldberg RM. Cancer and Leukemia Group B/Southwest Oncology Group trial 80405: a phase III trial of chemotherapy and biologics for patients with untreated advanced colorectal adenocarcinoma. Clin Colorectal Cancer. 2005 Nov;5(4):292-4. doi: 10.3816/ccc.2005.n.043. No abstract available. PubMed 16356309 ↗
  • Battaglin F, Ou FS, Qu X, Hochster HS, Niedzwiecki D, Goldberg RM, Mayer RJ, Ashouri K, Zemla TJ, Blanke CD, Venook AP, Kabbarah O, Lenz HJ, Innocenti F. HER2 Gene Expression Levels Are Predictive and Prognostic in Patients With Metastatic Colorectal Cancer Enrolled in CALGB/SWOG 80405. J Clin Oncol. 2024 Jun 1;42(16):1890-1902. doi: 10.1200/JCO.23.01507. Epub 2024 Mar 8. PubMed 38457761 ↗
  • Raghav K, Ou FS, Venook AP, Innocenti F, Sun R, Lenz HJ, Kopetz S. Acquired Genomic Alterations on First-Line Chemotherapy With Cetuximab in Advanced Colorectal Cancer: Circulating Tumor DNA Analysis of the CALGB/SWOG-80405 Trial (Alliance). J Clin Oncol. 2023 Jan 20;41(3):472-478. doi: 10.1200/JCO.22.00365. Epub 2022 Sep 6. PubMed 36067452 ↗
  • Yuan C, Sato K, Hollis BW, Zhang S, Niedzwiecki D, Ou FS, Chang IW, O'Neil BH, Innocenti F, Lenz HJ, Blanke CD, Goldberg RM, Venook AP, Mayer RJ, Fuchs CS, Meyerhardt JA, Ng K. Plasma 25-Hydroxyvitamin D Levels and Survival in Patients with Advanced or Metastatic Colorectal Cancer: Findings from CALGB/SWOG 80405 (Alliance). Clin Cancer Res. 2019 Dec 15;25(24):7497-7505. doi: 10.1158/1078-0432.CCR-19-0877. Epub 2019 Sep 23. PubMed 31548349 ↗
  • Guercio BJ, Zhang S, Ou FS, Venook AP, Niedzwiecki D, Lenz HJ, Innocenti F, O'Neil BH, Shaw JE, Polite BN, Hochster HS, Atkins JN, Goldberg RM, Sato K, Ng K, Van Blarigan E, Mayer RJ, Blanke CD, O'Reilly EM, Fuchs CS, Meyerhardt JA. Associations of Physical Activity With Survival and Progression in Metastatic Colorectal Cancer: Results From Cancer and Leukemia Group B (Alliance)/SWOG 80405. J Clin Oncol. 2019 Oct 10;37(29):2620-2631. doi: 10.1200/JCO.19.01019. Epub 2019 Aug 13. PubMed 31408415 ↗
  • Lenz HJ, Ou FS, Venook AP, Hochster HS, Niedzwiecki D, Goldberg RM, Mayer RJ, Bertagnolli MM, Blanke CD, Zemla T, Qu X, Wirapati P, Tejpar S, Innocenti F, Kabbarah O. Impact of Consensus Molecular Subtype on Survival in Patients With Metastatic Colorectal Cancer: Results From CALGB/SWOG 80405 (Alliance). J Clin Oncol. 2019 Aug 1;37(22):1876-1885. doi: 10.1200/JCO.18.02258. Epub 2019 May 1. PubMed 31042420 ↗
  • Venook AP, Niedzwiecki D, Lenz HJ, Innocenti F, Fruth B, Meyerhardt JA, Schrag D, Greene C, O'Neil BH, Atkins JN, Berry S, Polite BN, O'Reilly EM, Goldberg RM, Hochster HS, Schilsky RL, Bertagnolli MM, El-Khoueiry AB, Watson P, Benson AB 3rd, Mulkerin DL, Mayer RJ, Blanke C. Effect of First-Line Chemotherapy Combined With Cetuximab or Bevacizumab on Overall Survival in Patients With KRAS Wild-Type Advanced or Metastatic Colorectal Cancer: A Randomized Clinical Trial. JAMA. 2017 Jun 20;317(23):2392-2401. doi: 10.1001/jama.2017.7105. PubMed 28632865 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00265850
Lead sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI), SWOG Cancer Research Network, Bristol-Myers Squibb, Aptuit
Responsible party
Sponsor
First posted
Dec 15, 2005
Start date
Nov 2005
Primary completion
Feb 2015
Completion
Jan 2018
Results posted
Apr 26, 2017
Last update
Aug 7, 2026

Study contacts

Alan Venook, MD
study chair · University of California, San Francisco

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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