Bevacizumab and Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

Sponsor

Hopital Jean Minjoz (Other)

Overall Status

Unknown status

CT.gov ID

NCT00544011

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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

OBJECTIVES:

Primary

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

Secondary

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Apr 1, 2007

Outcome Measures

Primary Outcome Measures

Objective response (complete and partial) rate []

Secondary Outcome Measures

Progression-free survival []
Overall survival []
Tolerance []
Resectability rate []
Biomarkers predictive of efficacy []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

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