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CompletedNCT01229943Updated Aug 4, 2022Results posted

Everolimus and Octreotide Acetate With or Without Bevacizumab in Treating Patients With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors That Cannot Be Removed by Surgery

A Phase 2 interventional study of Bevacizumab and Everolimus in Advanced Pancreatic Neuroendocrine Tumor, Locally Advanced Pancreatic Neuroendocrine Tumor and Pancreatic Gastrinoma, sponsored by National Cancer Institute (NCI). Completed at 394 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-04.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This randomized phase II trial studies how well everolimus and octreotide acetate with or without bevacizumab works in treating patients with pancreatic neuroendocrine tumors that cannot be removed by surgery and have spread nearby or to other places in the body. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Octreotide acetate may interfere with and slow the growth of tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab and everolimus also may stop the growth of pancreatic neuroendocrine tumors by blocking blood flow to the tumor. It is not yet known whether giving everolimus and octreotide acetate together is more effective with or without bevacizumab in treating pancreatic neuroendocrine tumors.

Read the detailed description

PRIMARY OBJECTIVES:

l. To assess the progression-free survival rate of patients with locally advanced or metastatic pancreatic neuroendocrine tumors treated with everolimus alone or everolimus plus bevacizumab.

SECONDARY OBJECTIVES:

I. To compare progression-free survival (PFS) among treatment arms shown to be efficacious.

II. To estimate the overall tumor response rate in patients with metastatic pancreatic neuroendocrine tumors treated with one of two novel regimens.

III. To estimate the overall biochemical response rate (as measured by plasma chromogranin A levels) in patients with metastatic pancreatic neuroendocrine tumors treated with these regimens.

IV. To assess the toxicity of each regimen in patients with metastatic pancreatic neuroendocrine tumors.

V. To assess the overall survival of patients with pancreatic neuroendocrine tumors treated with these regimens.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive everolimus orally (PO) once daily (QD) on days 1-28 and octreotide acetate intramuscularly (IM) on day 1.

ARM II: Patients receive everolimus and octreotide acetate as in Arm I. Patients also receive bevacizumab intravenously (IV) over 30-90 minutes on days 1 and 15.

In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3-6 months for 3 years.

02

Conditions studied

  • Advanced Pancreatic Neuroendocrine Tumor
  • Locally Advanced Pancreatic Neuroendocrine Tumor
  • Pancreatic Gastrinoma
  • Pancreatic Neuroendocrine Tumor G1
  • Pancreatic Neuroendocrine Tumor G2
  • Pancreatic Vipoma
03

In context

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,554 studies on the registry; 334 are open to participants now.

Of its 407 completed or terminated interventional studies of FDA-regulated products, 370 (91%) have results posted.

Browse National Cancer Institute (NCI) studies →

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

Inclusion Criteria:

  • Patients must have histologic documentation of well-differentiated or moderately differentiated neuroendocrine tumor from either a primary or metastatic site

    • If different histologic classification schemes are used, equivalent histologic classifications (for example "grade 1", "low-grade", or "intermediate-grade") are allowed
    • Patients with poorly differentiated neuroendocrine carcinoma or small cell carcinoma are excluded
    • Documentation from a metastatic disease site is sufficient if there is clinical evidence of a pancreatic primary site
  • Locally unresectable or metastatic disease

  • Patients must have either histologic documentation of a pancreatic primary site, or clinical evidence of a pancreatic neuroendocrine primary tumor as determined by the treating physician

    • Patients with neuroendocrine tumors (e.g., gastrinoma, VIPoma) in whom a pancreatic or peripancreatic primary site is strongly suspected are also eligible
  • Patients must have evidence of disease (measurable or non-measurable) with evidence of progression within the past 12 months
  • Measurable disease:

Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 2 cm with conventional techniques or as >= 1 cm with spiral computed tomography (CT) scan

  • Non-measurable disease:

All other lesions, including small lesions (longest diameter \< 20 mm with conventional techniques or \< 10 mm with spiral CT scan) and truly non-measurable lesions; lesions that are considered non-measurable include the following:

  • Bone lesions
  • Leptomeningeal disease
  • Ascites
  • Pleural/pericardial effusion
  • Inflammatory breast disease
  • Lymphangitis cutis/pulmonis
  • Abdominal masses that are not confirmed and followed by imaging techniques

  • Cystic lesions

    • No prior treatment with bevacizumab, everolimus, or other mammalian target of rapamycin (mTOR) inhibitors
    • Other prior treatments, including but not limited to prior cytotoxic chemotherapy, alpha interferon, tyrosine kinase inhibitors, external beam radiation therapy, and radiopeptide therapy are allowed
  • There is no limit on the number of prior treatment regimens

  • Any prior treatment (with the exception of octreotide) must be completed at least 4 weeks prior to initiation of treatment

    • Prior treatment with embolization or ablative therapies is allowed if measurable disease remains outside of the treated area

  • There is no limit on the prior number of procedures

    • Treatment with somatostatin analogs is a requirement of the study
  • Patients receiving octreotide at the time of study entry may continue at the same dose level for the duration of the study
  • Patients not receiving octreotide will initiate treatment according to study guidelines

  • Prior progression on somatostatin analogs or a negative octreotide scan does not exclude patient participation in this study

    • Patients should have completed any major surgery >= 4 weeks from start of treatment
  • Patients must have completed any minor surgery >= 2 weeks prior to start of treatment
  • Patients must have fully recovered from the procedure

  • Insertion of a vascular access device is not considered major or minor surgery

    • Patients should not receive immunization with attenuated live vaccines within one week prior to registration or during protocol therapy
    • No concurrent condition resulting in immune compromise, including chronic treatment with corticosteroids or other immuno suppressive agents
    • No active or severe liver disease (e.g., acute or chronic hepatitis, cirrhosis); no positive anti-hepatitis B virus (HBV); HBV seropositive patients (hepatitis B surface antigen [HBsAg] positive) are eligible if they are closely monitored for evidence of active HBV infection by HBV deoxyribonucleic acid (DNA) testing, and they agree to receive suppressive therapy with lamivudine or other HBV-suppressive therapy until at least 4 weeks after the last dose of everolimus; patients who are hepatitis C antibody positive are eligible provided that hepatitis C viral load (hepatitis C ribonucleic acid [RNA]) is undetectable
    • No clinical evidence of brain metastases or carcinomatous meningitis
    • No history of gastrointestinal (GI) perforation within 12 months prior to registration
    • No history of clinically significant bleeding episodes
    • Patients on therapeutic anticoagulation are eligible for the study provided that they are on a stable dose of anticoagulants
    • No uncontrolled diabetes mellitus
    • Patients with a history of severely impaired lung function as defined as spirometry and diffusing capacity of the lung for carbon monoxide (DLCO) that is 50% of the normal predicted value and/or oxygen (O2) saturation that is 88% or less at rest on room air are excluded
    • Patients with fasting serum cholesterol >= 300 mg/dL OR >= 7.75 mmol/L AND fasting triglycerides >= 2.5 X upper limit of normal (ULN) should initiate lipid-lowering medications with the goal of achieving levels below these thresholds
    • No history of intolerance or allergies to octreotide
    • Patients with a history of hypertension must be adequately controlled (baseline blood pressure [BP] \< 150/90 mm Hg) on antihypertensives
    • No current congestive heart failure (New York Heart Association class II, III, or IV)
    • No symptomatic arterial peripheral vascular disease
    • No history of aortic aneurysm, aortic dissection, angina, myocardial infarction, stroke, or other arterial thrombotic events within 6 months of registration
    • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
    • Women must not be pregnant or lactating; both men and women of childbearing potential must be advised of the importance of using effective birth control measures during the course of the study
    • Granulocytes >= 1,500/uL
    • Platelets >= 100,000/uL
    • Creatinine =\< 1.5 x upper limit of normal
    • Bilirubin =\< 1.5 x upper limit of normal
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 2.5 x upper limit of normal (=\< 5 x upper limit of normal if liver metastases present)
    • Urine protein =\< 1+ OR urine creatinine ratio =\< 1 (by urinalysis)
  • If urine protein creatinine (UPC) ratio is > 1 on urinalysis, then 24-hour urine collection for protein must be obtained and level must be \< 1,000 mg for patient enrollment
05

Study design

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

Study arms

  • Experimental
    Arm I (octreotide acetate and everolimus)

    Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1.

    Drug: Everolimus · Drug: Octreotide Acetate

  • Experimental
    Arm II (octreotide acetate, everolimus, and bevacizumab)

    Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15.

    Biological: Bevacizumab · Drug: Everolimus · Drug: Octreotide Acetate

Interventions

  • BiologicalBevacizumab

    Given IV

    Also known as: ABP 215, Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF Monoclonal Antibody SIBP04, Anti-VEGF rhuMAb, Avastin, Bevacizumab awwb, Bevacizumab Biosimilar ABP 215, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar CT-P16, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar GB-222, Bevacizumab Biosimilar HD204, Bevacizumab Biosimilar HLX04, Bevacizumab Biosimilar IBI305, Bevacizumab Biosimilar LY01008, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar Mvasi, Bevacizumab Biosimilar MYL-1402O, Bevacizumab Biosimilar QL 1101, Bevacizumab Biosimilar RPH-001, Bevacizumab Biosimilar SCT501, Bevacizumab Biosimilar Zirabev, Bevacizumab-awwb, Bevacizumab-bvzr, BP102, BP102 Biosimilar, HD204, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Mvasi, MYL-1402O, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF, SCT501, SIBP 04, SIBP-04, SIBP04, Zirabev

  • DrugEverolimus

    Given PO

    Also known as: 42-O-(2-Hydroxy)ethyl Rapamycin, Afinitor, Certican, RAD 001, RAD001, Votubia, Zortress

  • DrugOctreotide Acetate

    Given IM

    Also known as: D-Phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[(1R,2R)-2-hydroxy-1-(hyroxymethyl)propyl]-L-cysteinamide, Cyclic (2->7)-disulfide, Acetate (Salt), Longastatin, Longastatina, Samilstin, Sandostatin, Sandostatin Lar Depot, Sandostatina, Sandostatine, SMS 201-995, SMS 201-995 AC

06

What researchers measure

Primary outcomes

  1. Progression Free Survival

    Progression Free Survival (PFS) was defined as the time from study entry until disease progression or death, whichever occurs first. The median PFS was estimated using the Kaplan-Meier method. Progression was assessed per RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions (and an absolute increase of at least 0.5 cm) or the appearance of new lesions.

    Time frame: From study entry to the date of documented progression or death from any cause, up to 3 years

Secondary outcomes

  1. Overall Response Rate

    The proportion of patients who respond (completely or partially) to each combination regimen will be estimated. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions.

    Time frame: Up to 3 years

  2. Overall Survival (OS)

    Overall survival (OS) is defined as the time from study entry to death from any cause. The median OS was estimated using the Kaplan-Meier method.

    Time frame: From registration to time of death, assessed up to 3 years

07

Results

Posted Feb 11, 2016

Participant flow

From October 2010 to October 2012, 150 participants were recruited and randomized to study treatment.

Participant flow — Overall Study
MilestoneArm I (Octreotide Acetate and Everolimus)Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)
Started7575
Completed5758
Not completed1817

Outcome measures

PrimaryProgression Free Survival

Progression Free Survival (PFS) was defined as the time from study entry until disease progression or death, whichever occurs first. The median PFS was estimated using the Kaplan-Meier method. Progression was assessed per RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions (and an absolute increase of at least 0.5 cm) or the appearance of new lesions.

Time frame:
From study entry to the date of documented progression or death from any cause, up to 3 years
Reported as:
Median · months
Progression Free Survival
monthsArm I (Octreotide Acetate and Everolimus)Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)
Progression Free Survival14.0 (9.1 to 16.9)16.7 (12.6 to 19.7)
Statistical analysis
  • Arm I (Octreotide Acetate and Everolimus) vs Arm II (Octreotide Acetate, Everolimus, and Bevacizumab) · Log Rank · p = 0.12 (Tests were stratified by: prior treatment with cytotoxic chemotherapy (no vs yes), prior use of octreotide (no vs yes), and prior therapy with sunitinib (no vs yes).) · Hazard ratio (hr): 0.80 · 95% CI 0.55 to 1.17
SecondaryOverall Response Rate

The proportion of patients who respond (completely or partially) to each combination regimen will be estimated. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions.

Time frame:
Up to 3 years
Reported as:
Number · percentage of participants
Overall Response Rate
percentage of participantsArm I (Octreotide Acetate and Everolimus)Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)
Overall Response Rate1231
SecondaryOverall Survival (OS)

Overall survival (OS) is defined as the time from study entry to death from any cause. The median OS was estimated using the Kaplan-Meier method.

Time frame:
From registration to time of death, assessed up to 3 years
Reported as:
Median · months
Overall Survival (OS)
monthsArm I (Octreotide Acetate and Everolimus)Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)
Overall Survival (OS)35.0 (29.9 to NA)36.7 (31.8 to NA)

Adverse events

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

Adverse event summary by group
GroupDeathsSeriousOther
Arm I (Octreotide Acetate and Everolimus)—20/74 (27%)73/74 (98.6%)
Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)—31/73 (42.5%)72/73 (98.6%)
Most frequent serious events
Showing 10 of 155
Most frequent serious events
EventArm I (Octreotide Acetate and Everolimus)Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)
FatigueGeneral disorders15/7421/73
HyperglycemiaMetabolism and nutrition disorders10/7421/73
HypertensionVascular disorders6/7418/73
AnemiaBlood and lymphatic system disorders4/7416/73
DiarrheaGastrointestinal disorders5/7414/73
NauseaGastrointestinal disorders8/7413/73
ProteinuriaRenal and urinary disorders1/7413/73
Aspartate aminotransferase increasedInvestigations8/7412/73
Weight lossInvestigations0/7412/73
Edema limbsGeneral disorders2/7411/73
Most frequent other events
Showing 10 of 280
Most frequent other events
EventArm I (Octreotide Acetate and Everolimus)Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)
FatigueGeneral disorders60/7463/73
HypertensionVascular disorders38/7459/73
HyperglycemiaMetabolism and nutrition disorders54/7456/73
DiarrheaGastrointestinal disorders48/7450/73
Mucositis oralGastrointestinal disorders48/7443/73
ProteinuriaRenal and urinary disorders12/7446/73
EpistaxisRespiratory, thoracic and mediastinal disorders11/7446/73
AnemiaBlood and lymphatic system disorders29/7440/73
Aspartate aminotransferase increasedInvestigations38/7440/73
NauseaGastrointestinal disorders36/7438/73

Baseline characteristics

Age, Continuous
Age, Continuous(years)Arm I (Octreotide Acetate and Everolimus)Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)Total
Median59 (23 to 80)58 (21 to 86)58.5 (21 to 86)
Sex: Female, Male
Sex: Female, Male(Participants)Arm I (Octreotide Acetate and Everolimus)Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)Total
Female353166
Male404484
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Arm I (Octreotide Acetate and Everolimus)Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)Total
Hispanic or Latino314
Not Hispanic or Latino6970139
Unknown or Not Reported347
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Arm I (Octreotide Acetate and Everolimus)Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)Total
American Indian or Alaska Native011
Asian426
Native Hawaiian or Other Pacific Islander101
Black or African American4812
White6461125
More than one race000
Unknown or Not Reported235
Region of Enrollment
Region of Enrollment(participants)Arm I (Octreotide Acetate and Everolimus)Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)Total
Canada5611
United States7069139
08

Study locations

394 sites
  • Providence Hospital
    Mobile, Alabama 36608, United States
  • Kaiser Permanente-Anaheim
    Anaheim, California 92806, United States
  • Kaiser Permanente-Deer Valley Medical Center
    Antioch, California 94531, United States
  • Kaiser Permanente-Baldwin Park
    Baldwin Park, California 91706, United States
  • Kaiser Permanente-Bellflower
    Bellflower, California 90706, United States
  • Alta Bates Summit Medical Center-Herrick Campus
    Berkeley, California 94704, United States
  • Mills-Peninsula Medical Center
    Burlingame, California 94010, United States
  • Kaiser Permanente-Fontana
    Fontana, California 92335, United States
  • Kaiser Permanente-Fremont
    Fremont, California 94538, United States
  • Kaiser Permanente-Fresno
    Fresno, California 93720, United States
  • Kaiser Permanente - Harbor City
    Harbor City, California 90710, United States
  • Kaiser Permanente-Irvine
    Irvine, California 92618, United States
  • Kaiser Permanente Los Angeles Medical Center
    Los Angeles, California 90027, United States
  • Kaiser Permanente West Los Angeles
    Los Angeles, California 90034, United States
  • Cedars Sinai Medical Center
    Los Angeles, California 90048, United States
  • Sutter Cancer Research Consortium
    Novato, California 94945, United States
  • Kaiser Permanente-Oakland
    Oakland, California 94611, United States
  • Stanford Cancer Institute Palo Alto
    Palo Alto, California 94304, United States
  • Kaiser Permanente - Panorama City
    Panorama City, California 91402, United States
  • Kaiser Permanente-Redwood City
    Redwood City, California 94063, United States
  • Kaiser Permanente-Richmond
    Richmond, California 94801, United States
  • Kaiser Permanente-Riverside
    Riverside, California 92505, United States
  • Kaiser Permanente-Roseville
    Roseville, California 95661, United States
  • Kaiser Permanente-South Sacramento
    Sacramento, California 95823, United States
  • Kaiser Permanente - Sacramento
    Sacramento, California 95825, United States
  • Kaiser Permanente-San Diego Mission
    San Diego, California 92108, United States
  • Kaiser Permanente-San Diego Zion
    San Diego, California 92120, United States
  • California Pacific Medical Center-Pacific Campus
    San Francisco, California 94115, United States
  • Kaiser Permanente-San Francisco
    San Francisco, California 94115, United States
  • UCSF Medical Center-Mount Zion
    San Francisco, California 94115, United States
  • Kaiser Permanente-Santa Teresa-San Jose
    San Jose, California 95119, United States
  • Kaiser Permanente San Leandro
    San Leandro, California 94577, United States
  • Kaiser Permanente-San Marcos
    San Marcos, California 92078, United States
  • Kaiser Permanente-San Rafael
    San Rafael, California 94903, United States
  • Kaiser Permanente Medical Center - Santa Clara
    Santa Clara, California 95051, United States
  • Kaiser Permanente-Santa Rosa
    Santa Rosa, California 95403, United States
  • Sutter Pacific Medical Foundation
    Santa Rosa, California 95403, United States
  • Kaiser Permanente-South San Francisco
    South San Francisco, California 94080, United States
  • Kaiser Permanente-Stockton
    Stockton, California 95210, United States
  • Kaiser Permanente Medical Center-Vacaville
    Vacaville, California 95688, United States
  • Kaiser Permanente-Vallejo
    Vallejo, California 94589, United States
  • Sutter Solano Medical Center/Cancer Center
    Vallejo, California 94589, United States
  • Kaiser Permanente-Walnut Creek
    Walnut Creek, California 94596, United States
  • Kaiser Permanente-Woodland Hills
    Woodland Hills, California 91367, United States
  • The Medical Center of Aurora
    Aurora, Colorado 80012, United States
  • Boulder Community Hospital
    Boulder, Colorado 80301, United States
  • Penrose-Saint Francis Healthcare
    Colorado Springs, Colorado 80907, United States
  • Porter Adventist Hospital
    Denver, Colorado 80210, United States
  • Presbyterian - Saint Lukes Medical Center - Health One
    Denver, Colorado 80218, United States
  • SCL Health Saint Joseph Hospital
    Denver, Colorado 80218, United States
  • Rose Medical Center
    Denver, Colorado 80220, United States
  • Western States Cancer Research NCORP
    Denver, Colorado 80222, United States
  • Swedish Medical Center
    Englewood, Colorado 80113, United States
  • Saint Mary's Hospital and Regional Medical Center
    Grand Junction, Colorado 81501, United States
  • North Colorado Medical Center
    Greeley, Colorado 80631, United States
  • Saint Anthony Hospital
    Lakewood, Colorado 80228, United States
  • Littleton Adventist Hospital
    Littleton, Colorado 80122, United States
  • Sky Ridge Medical Center
    Lone Tree, Colorado 80124, United States
  • Longmont United Hospital
    Longmont, Colorado 80501, United States
  • McKee Medical Center
    Loveland, Colorado 80539, United States
  • Parker Adventist Hospital
    Parker, Colorado 80138, United States
  • Saint Mary Corwin Medical Center
    Pueblo, Colorado 81004, United States
  • North Suburban Medical Center
    Thornton, Colorado 80229, United States
  • SCL Health Lutheran Medical Center
    Wheat Ridge, Colorado 80033, United States
  • Smilow Cancer Hospital Care Center at Saint Francis
    Hartford, Connecticut 06105, United States
  • The Hospital of Central Connecticut
    New Britain, Connecticut 06050, United States
  • Beebe Medical Center
    Lewes, Delaware 19958, United States
  • Christiana Care Health System-Christiana Hospital
    Newark, Delaware 19718, United States
  • MedStar Georgetown University Hospital
    Washington D.C., District of Columbia 20007, United States
  • MedStar Washington Hospital Center
    Washington D.C., District of Columbia 20010, United States
  • Lakeland Regional Health Hollis Cancer Center
    Lakeland, Florida 33805, United States
  • AdventHealth Orlando
    Orlando, Florida 32803, United States
  • Augusta University Medical Center
    Augusta, Georgia 30912, United States
  • Hawaii Cancer Care Inc - Waterfront Plaza
    Honolulu, Hawaii 96813, United States
  • Queen's Medical Center
    Honolulu, Hawaii 96813, United States
  • Straub Clinic and Hospital
    Honolulu, Hawaii 96813, United States
  • University of Hawaii Cancer Center
    Honolulu, Hawaii 96813, United States
  • Hawaii Cancer Care Inc-Liliha
    Honolulu, Hawaii 96817, United States
  • Queen's Cancer Center - Kuakini
    Honolulu, Hawaii 96817, United States
  • The Cancer Center of Hawaii-Liliha
    Honolulu, Hawaii 96817, United States
  • Kaiser Permanente Moanalua Medical Center
    Honolulu, Hawaii 96819, United States
  • Kapiolani Medical Center for Women and Children
    Honolulu, Hawaii 96826, United States
  • Castle Medical Center
    Kailua, Hawaii 96734, United States
  • Wilcox Memorial Hospital and Kauai Medical Clinic
    Lihue, Hawaii 96766, United States
  • Maui Memorial Medical Center
    Wailuku, Hawaii 96793, United States
  • Pacific Cancer Institute of Maui
    Wailuku, Hawaii 96793, United States
  • Pali Momi Medical Center
    ‘Aiea, Hawaii 96701, United States
  • Saint Alphonsus Cancer Care Center-Boise
    Boise, Idaho 83706, United States
  • Hematology and Oncology Associates
    Chicago, Illinois 60611, United States
  • Northwestern University
    Chicago, Illinois 60611, United States
  • University of Chicago Comprehensive Cancer Center
    Chicago, Illinois 60637, United States
  • Advocate Sherman Hospital
    Elgin, Illinois 60123, United States
  • Hematology Oncology Associates of Illinois-Highland Park
    Highland Park, Illinois 60035, United States
  • Presence Saint Mary's Hospital
    Kankakee, Illinois 60901, United States
  • AMITA Health Adventist Medical Center
    La Grange, Illinois 60525, United States
  • AMG Libertyville - Oncology
    Libertyville, Illinois 60048, United States
  • Loyola University Medical Center
    Maywood, Illinois 60153, United States
  • Garneau, Stewart C MD (UIA Investigator)
    Moline, Illinois 61265, United States
  • Porubcin, Michael MD (UIA Investigator)
    Moline, Illinois 61265, United States
  • Spector, David MD (UIA Investigator)
    Moline, Illinois 61265, United States

Showing the first 100 of 394 sites across 2 countries.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2010 to primary completion in Sep 2014, 46 months.

Results were first posted in Feb 2016, 1 year 5 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 27, 2010
First posted
Oct 28, 2010
StartActual
Oct 15, 2010
Primary completionActual
Sep 1, 2014
CompletionActual
Jan 3, 2018
Results first posted
Feb 11, 2016
Last update
Aug 4, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01229943
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Oct 28, 2010
Start date
Oct 15, 2010
Primary completion
Sep 1, 2014
Completion
Jan 3, 2018
Results posted
Feb 11, 2016
Last update
Aug 4, 2022

Study contacts

Matthew H Kulke
principal investigator · Alliance for Clinical Trials in Oncology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Bevacizumab

Other studies in this condition

Vipoma

Other studies from this sponsor

National Cancer Institute (NCI) →

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