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Trial record 1 of 1 for:    NCT00467142
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Bevacizumab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed by Surgery

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ClinicalTrials.gov Identifier: NCT00467142
Recruitment Status : Completed
First Posted : April 27, 2007
Last Update Posted : May 16, 2011
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Monoclonal antibodies, such as 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. Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with combination chemotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with combination chemotherapy works as first-line therapy in treating patients with metastatic colorectal cancer that cannot be removed by surgery.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Biological: bevacizumab Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Genetic: polymorphism analysis Phase 2

Detailed Description:

OBJECTIVES:

Primary

  • Determine the efficacy of bevacizumab, irinotecan hydrochloride, leucovorin calcium, and fluorouracil, in terms of partial or complete response, in patients with unresectable metastatic colorectal cancer.

Secondary

  • Determine the duration of response in patients treated with this regimen.
  • Determine the overall survival and progression-free survival of patients treated with this regimen.
  • Determine the tolerability of this regimen in these patients.
  • Assess the pharmacogenetics and change in genetic polymorphisms susceptible to modification by this regimen.

OUTLINE: This is a nonrandomized, multicenter study.

Patients receive irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and bevacizumab IV on day 1. Patients also receive fluorouracil IV over 46 hours beginning on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.

Blood and tissue samples are collected periodically for pharmacogenetic and genetic polymorphism analysis.

PROJECTED ACCRUAL: A total of 61 patients will be accrued for this study.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 61 participants
Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: Phase II Study Evaluating the Efficacy and Tolerance to Chemotherapy With 5-fluorouracil, Folinic Acid, Irinotecan and Bevacizumab as First-line Treatment in Patients With Metastatic Colorectal Cancer
Study Start Date : January 2007
Actual Primary Completion Date : May 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab




Primary Outcome Measures :
  1. Partial or complete response rate

Secondary Outcome Measures :
  1. Duration of response
  2. Overall and progression-free survival
  3. Tolerance to treatment
  4. Modified genetic polymorphisms and pharmacogenetics


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the colon or rectum

    • No other histological types
  • Metastatic, unresectable disease

    • No bone metastases only
  • Unidimensionally measurable metastatic disease
  • No CNS metastases

PATIENT CHARACTERISTICS:

  • WHO performance status (PS) 0-2 OR Karnofsky PS 70-100%
  • Life expectancy ≥ 12 weeks
  • ANC > 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 10 g/dL
  • Bilirubin ≤ 1.25 times normal (1.5 times normal in presence of hepatic metastases)
  • AST and ALT < 3 times normal (5 times normal in presence of hepatic metastases)
  • Creatinine < 1.25 times normal
  • No proteinuria
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other cancer in the past 5 years except for carcinoma in situ of the uterine cervix or basal cell skin cancer
  • No hypersensitivity to fluorouracil
  • No hypersensitivity to leucovorin calcium, bevacizumab, or their excipients
  • No hypersensitivity to Chinese hamster ovarian cell products or other recombinant humanized or nonhumanized monoclonal antibodies
  • No allergy to irinotecan hydrochloride
  • No prior reaction to attenuated vaccines (fever, jaundice)
  • No poor nutritional status
  • No Biermer anemia or other anemia due to vitamin B12 deficiency
  • No uncontrolled symptomatic occlusion or subocclusion
  • No medullary hypoplasia or severe insufficiency
  • No prior chronic intestinal disease
  • No Gilbert's syndrome
  • No intra-abdominal inflammatory reaction (e.g., gastroduodenal ulcer, diverticulitis, or colitis)
  • No chronic intestinal inflammatory disease
  • No thromboembolic arterial condition in the past 6 months, including any of the following:

    • Cardiovascular accident
    • Transient ischemic attack
    • Myocardial infarction
  • No infection or serious noncancerous disease
  • No condition that is unstable or would increase risk to the patient, including any of the following:

    • Unstable angina
    • Poorly controlled hypertension
    • Severe cardiac insufficiency
    • Serious arrhythmia
    • Bleeding diathesis
    • Pulmonary disease at risk of decompensation
  • No familial, geographical, social, or psychological condition that would preclude study participation
  • No prisoners or patients without guardians

PRIOR CONCURRENT THERAPY:

  • At least 8 weeks since prior surgery
  • At least 6 months since prior adjuvant chemotherapy
  • At least 1 month since prior palliative chemotherapy
  • No prior abdominal or pelvic radiotherapy
  • At least 30 days since prior participation in another investigational study
  • No prior bevacizumab
  • No extensive intestinal resection (e.g., partial colectomy or extensive thin resection)
  • No concurrent warfarin, Hypericum perforatum (St. John's wort), or prophylactic phenytoin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00467142


Locations
France
Institut Bergonie
Bordeaux, France, 33076
Sponsors and Collaborators
Institut Bergonié
Investigators
Study Chair: Yves Becouarn, MD Institut Bergonié

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00467142     History of Changes
Other Study ID Numbers: CDR0000540522
IB-2006-31
IB-OMEGA
INCA-RECF0387
EUDRACT-2006-003901-22
First Posted: April 27, 2007    Key Record Dates
Last Update Posted: May 16, 2011
Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum
recurrent colon cancer
recurrent rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Irinotecan
Fluorouracil
Levoleucovorin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors