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Status unknownNCT00513266Updated Aug 7, 2009

Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer With Liver Metastases or Lung Metastases That Are Potentially Removable by Surgery

A Phase 2 interventional study of bevacizumab and cetuximab in Colorectal Cancer and Metastatic Cancer, sponsored by Centre Hospitalier Universitaire Vaudois. Status unknown at 4 sites in Switzerland. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2009-08-07.

Sponsored by Centre Hospitalier Universitaire Vaudois · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2009), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
35
Ages
18 Years to 70 Years
Sex
All
01

Study summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, irinotecan, fluorouracil and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab and cetuximab, 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. Giving combination chemotherapy together with monoclonal antibody therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with monoclonal antibody therapy works in treating patients with advanced colorectal cancer with liver metastases or lung metastases that are potentially removable by surgery.

Read the detailed description

OBJECTIVES:

Primary

  • To determine the pathological complete response (CR) rate in resected patients assessed on lesions of less than or equal to 30 mm in size.

Secondary

  • To determine the clinical CR rate in all patients.
  • To determine toxicity and tolerability of this regimen (pre- and postoperative toxicity).
  • To evaluate perioperative safety in these patients.
  • To determine disease-free survival (time to progression in unresected patients) and overall survival of the whole study population.
  • To determine resectability in these patients.
  • To evaluate markers that predict the occurrence of a pathological CR or a non-response in pathological material (resected liver metastasis) and biological material collected from these patients.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, oxaliplatin IV over 2 hours on days 1 and 15, irinotecan hydrochloride IV over 30 minutes on days 8 and 22, fluorouracil IV over 24 hours on days 1, 8, 15, and 22, leucovorin calcium IV on days 1, 8, 15, and 22, and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 5 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Patients who are able to undergo liver resection receive bevacizumab on day 1 only of course 3 and undergo liver resection 3 weeks after chemotherapy. Beginning 4 weeks after liver resection, patients receive 2 additional courses of chemotherapy as adjuvant therapy.

Patients undergo tumor tissue and blood sample collection periodically for biological studies. Samples are analyzed for markers that predict the occurrence of a complete pathological response (pCR) or a non-response.

After completion of study treatment, patients are followed every 3 months for the first 2 years and then every 6 months thereafter.

02

Conditions studied

  • Colorectal Cancer
  • Metastatic Cancer

Keywords

  • recurrent rectal cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • stage IV colon cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • liver metastases
  • lung metastases
03

In context

Colorectal Neoplasms

5,598 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.

This study's planned enrollment of 35 is below the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Centre Hospitalier Universitaire Vaudois is the lead sponsor of 203 studies on the registry; 47 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

  • Histologically confirmed metastatic colorectal adenocarcinoma
  • Bidimensionally measurable metastatic disease limited to the liver and considered curatively resectable after response to systemic therapy as assessed by a surgical board

    • Additional metastatic disease to the lungs consisting of no more than 3 potentially resectable lesions allowed
    • Must have at least one lesion of 30 mm or less

Exclusion criteria:

  • History or evidence upon physical examination of CNS disease unless adequately treated (e.g., uncontrolled seizure with standard medical therapy or history of stroke)

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • Performance status ≤ 1
  • Life expectancy > 12 weeks
  • WBC ≥ 3,000/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Creatinine 1.25 x upper limit of normal (ULN)
  • Bilirubin 1.25 x ULN (1.5 x ULN if liver metastasis)
  • AST and ALT ≤ 3 x ULN (≤ 5 x ULN if liver metastasis)
  • Woman and men of childbearing age must use adequate contraception

Exclusion criteria:

  • Pregnancy (positive serum pregnancy test) or lactation
  • Chronic diarrhea ≥ grade 2
  • Other serious illness or medical condition including any of the following:

    • Unstable cardiac disease requiring treatment
    • Congestive heart failure or angina pectoris even if medically controlled
    • Significant arrhythmias
    • History of significant neurologic or psychiatric disorders including psychotic disorders, dementia, or seizures that would prohibit the understanding and giving of informed consent
    • Active uncontrolled infection
    • Severe hypercalcemia
    • Other serious underlying medical condition that could impair the ability of the patient to participate in the study
    • Neuropathy > grade 1 of any etiology
  • Known DPD deficiency
  • Known severe polyneuropathy
  • Known allergy to Chinese hamster ovary cell proteins, other recombinant human or humanized antibodies, any excipients of bevacizumab formulation, or any other study drugs
  • Chronic inflammatory bowel disease
  • Acute or subacute intestinal occlusion
  • History of previous arterial thromboembolism
  • Uncontrolled hypertension
  • Evidence of bleeding diathesis or coagulopathy
  • Serious nonhealing wound, ulcer, or bone fracture
  • History of tumor other than basocellular carcinoma of the skin
  • Peripheral neuropathy > grade 1 of any origin (e.g., alcohol)
  • Significant traumatic injury within 28 days prior to study treatment

PRIOR CONCURRENT THERAPY:

Exclusion criteria:

  • No prior chemotherapy for metastatic disease

    • Prior adjuvant chemotherapy permitted if interval since last treatment administration and recurrence is > 6 months
  • Major surgical procedure or open biopsy within 28 days prior to study treatment or anticipation of the need for major surgical procedure during the course of the study
  • Treatment in a clinical trial within 30 days prior to study entry
  • Concurrent treatment with other experimental drugs or other anticancer therapy
  • Current or recent use (within 10 days prior to study treatment) of full-dose oral or parenteral anticoagulants for therapeutic purposes
  • Chronic daily treatment with aspirin (> 325 mg/day)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrollment
35 participants (estimated)

Interventions

  • Biologicalbevacizumab
  • Biologicalcetuximab
  • Drugfluorouracil
  • Drugirinotecan hydrochloride
  • Drugleucovorin calcium
  • Drugoxaliplatin
  • Otherlaboratory biomarker analysis
  • Procedureadjuvant therapy
  • Procedurebiopsy
  • Procedureconventional surgery
  • Procedureneoadjuvant therapy
06

What researchers measure

Primary outcomes

  1. Pathological complete response rate of lesions of less than or equal to 30 mm in size assessed by pathologic examination in resected specimens

Secondary outcomes

  1. Response as assessed by NCIC criteria

  2. Toxicity as assessed by NCIC criteria

07

Study locations

4 sites
  • Kantonspital Aarau
    Chur, CH-7000, Switzerland
  • Hopital Cantonal Universitaire de Geneve
    Geneva, CH-1211, Switzerland
  • Centre Hospitalier Universitaire Vaudois
    Lausanne, CH-1011, Switzerland
  • Hopital Regional de Sion-Herens-Conthey
    Sion, CH -1951, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00513266
Lead sponsor
Centre Hospitalier Universitaire Vaudois
First posted
Aug 8, 2007
Start date
Jun 2007
Last update
Aug 7, 2009

Study contacts

Arnaud Roth, MD
study chair · Hopital Cantonal Universitaire de Geneve
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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