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Bevacizumab and Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00544011
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : October 16, 2007
Last Update Posted : June 27, 2011
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. Drugs used in chemotherapy, such as irinotecan, fluorouracil, and capecitabine, 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 bevacizumab given together with combination chemotherapy works in treating patients with metastatic colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Biological: bevacizumab Drug: capecitabine Drug: fluorouracil Drug: irinotecan hydrochloride Other: diagnostic laboratory biomarker analysis Phase 2

Detailed Description:



  • Evaluate the objective response (complete and partial) rate in patients with metastatic colorectal adenocarcinoma treated with bevacizumab and modified FOLFIRI 3 chemotherapy.


  • Determine progression-free and overall survival.
  • Determine the tolerance to this regimen.
  • Evaluate the resectability rate.
  • Evaluate biological markers predictive of the efficacy of this regimen.

OUTLINE: This is a multicenter study.

Patients receive bevacizumab IV over 30-90 minutes on day 1, irinotecan hydrochloride IV over 90 minutes on days 1 and 3, and fluorouracil IV continuously over 46 hours on day 1. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

At 14 days after completing chemotherapy, patients with progressive or stable disease receive maintenance therapy comprising bevacizumab and capecitabine.

Biological specimens are collected at baseline and before the fourth course of chemotherapy.

After completion of study therapy, patients are followed every 3 months for 2 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 47 participants
Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: Phase II Study Evaluating the Association of Bevacizumab and Chemotherapy of the Type Modified FOLFIRI 3 in Patients With Metastatic Colorectal Adenocarcinoma
Study Start Date : April 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Primary Outcome Measures :
  1. Objective response (complete and partial) rate

Secondary Outcome Measures :
  1. Progression-free survival
  2. Overall survival
  3. Tolerance
  4. Resectability rate
  5. Biomarkers predictive of efficacy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the colon or rectum

    • Previously untreated metastatic disease
  • Measurable disease by RECIST

    • Must not be located in a prior radiation field
  • No cerebral or meningeal metastases


Inclusion criteria:

  • WHO performance status 0-1
  • Life expectancy > 12 weeks
  • Absolute neutrophil count ≥ 1,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Transaminases ≤ 2 times ULN (5 times ULN if liver metastases present)
  • Alkaline phosphatase ≤ 2 times ULN (5 times ULN if liver metastases present)
  • Creatinine ≤ 130 μmol/L OR creatinine clearance ≥ 30 mL/min
  • Proteinuria < 2+ or urine protein ≤ 1 g/24 hours
  • Not pregnant or nursing
  • Fertile patients of must use effective contraception

Exclusion criteria:

  • Uncontrolled cardiac disease
  • Prior cerebral vascular accident
  • Uncontrolled arterial hypertension
  • Severe renal or hepatic insufficiency
  • Prior arteriopathy
  • Bleeding disorder or nonhealing wound
  • Coagulopathy
  • Other malignancy within the past 2 years except basal cell or squamous cell skin cancer or curatively treated carcinoma of the cervix
  • Psychiatric disorder compromising comprehension or participation in the study
  • Intestinal occlusion or subocclusion not caused by medical therapy


Inclusion criteria:

  • See Disease Characteristics

Exclusion criteria:

  • Prior adjuvant bevacizumab or irinotecan hydrochloride
  • Concurrent aspirin (> 325 mg/day) or therapeutic anticoagulants
  • Surgery in the past 28 days

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 identifier (NCT number): NCT00544011

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Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz Recruiting
Besancon, France, 25030
Contact: Christophe Borg, PhD    33-381-668-705   
Sponsors and Collaborators
Hopital Jean Minjoz
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OverallOfficial: Christophe Borg, PhD Hopital Jean Minjoz
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00544011    
Other Study ID Numbers: CDR0000564118
First Posted: October 16, 2007    Key Record Dates
Last Update Posted: June 27, 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
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors