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Combination Chemotherapy Plus Bevacizumab in Treating Patients With Advanced Colorectal Cancer

Phase 2
Completed
Conditions
Colorectal Cancer
Registration Number
NCT00006786
Lead Sponsor
Eastern Cooperative Oncology Group
Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bevacizumab may stop the growth of colorectal cancer by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus bevacizumab in treating patients who have advanced colorectal cancer.

Detailed Description

OBJECTIVES: I. Determine the progression-free survival at 7 months of patients with previously untreated advanced colorectal cancer treated with fluorouracil, leucovorin calcium, irinotecan, and bevacizumab. II. Determine the response rate and overall survival of this patient population treated with this regimen. III. Determine the toxicity of this treatment regimen in these patients.

OUTLINE: This is a multicenter study. Patients receive irinotecan IV over 90 minutes, leucovorin calcium IV, and fluorouracil IV once weekly for 4 weeks. Patients also receive bevacizumab IV over 30-90 minutes once every 2 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 1 year.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (77)

CCOP - Scottsdale Oncology Program

🇺🇸

Scottsdale, Arizona, United States

Cancer Center and Beckman Research Institute, City of Hope

🇺🇸

Duarte, California, United States

Veterans Affairs Medical Center - Palo Alto

🇺🇸

Palo Alto, California, United States

Stanford University Medical Center

🇺🇸

Stanford, California, United States

CCOP - Colorado Cancer Research Program, Inc.

🇺🇸

Denver, Colorado, United States

CCOP - Christiana Care Health Services

🇺🇸

Wilmington, Delaware, United States

MBCCOP-Howard University Cancer Center

🇺🇸

Washington, District of Columbia, United States

Walter Reed Army Medical Center

🇺🇸

Washington, District of Columbia, United States

Veterans Affairs Medical Center - Gainsville

🇺🇸

Gainesville, Florida, United States

Veterans Affairs Medical Center - Miami

🇺🇸

Miami, Florida, United States

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CCOP - Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
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