Colon Cancer Clinical Trial

Combination Chemotherapy Plus Bevacizumab in Treating Patients With Advanced Colorectal Cancer

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed advanced or metastatic adenocarcinoma of the colon and rectum Surgically unresectable disease Measurable disease Disease outside the prior radiotherapy port and/or progressive disease within the previously irradiated volume

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 No hemorrhagic events within the past 6 months Hepatic: Bilirubin normal SGOT normal INR no greater than 1.5 Renal: Creatinine no greater than 1.5 times upper limit of normal Cardiovascular: No thromboembolic events within the past 6 months Pulmonary: No evidence of pneumonia Other: No known hypersensitivity to recombinant humanized murine monoclonal antibodies No evidence of significant active infection (e.g., peritonitis or wound abscess) Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent sargramostim (GM-CSF) Chemotherapy: At least 12 months since prior fluorouracil-based adjuvant chemotherapy No prior adjuvant irinotecan Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 2 weeks since prior radiotherapy and recovered Surgery: See Disease Characteristics Other: No prior therapy for advanced disease No concurrent therapeutic anticoagulation except for low-dose coumadin for maintenance of indwelling catheters

Study is for people with:

Colon Cancer

Phase:

Phase 2

Study ID:

NCT00006786

Recruitment Status:

Completed

Sponsor:

Eastern Cooperative Oncology Group

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There are 71 Locations for this study

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CCOP - Scottsdale Oncology Program
Scottsdale Arizona, 85259, United States
Cancer Center and Beckman Research Institute, City of Hope
Duarte California, 91010, United States
Veterans Affairs Medical Center - Palo Alto
Palo Alto California, 94304, United States
Stanford University Medical Center
Stanford California, 94305, United States
CCOP - Colorado Cancer Research Program, Inc.
Denver Colorado, 80209, United States
CCOP - Christiana Care Health Services
Wilmington Delaware, 19899, United States
MBCCOP-Howard University Cancer Center
Washington District of Columbia, 20060, United States
Walter Reed Army Medical Center
Washington District of Columbia, 20307, United States
Veterans Affairs Medical Center - Gainsville
Gainesville Florida, 32608, United States
Veterans Affairs Medical Center - Miami
Miami Florida, 33125, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States
Veterans Affairs Medical Center - Tampa (Haley)
Tampa Florida, 33612, United States
Emory University Hospital - Atlanta
Atlanta Georgia, 30322, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur Georgia, 30033, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago Illinois, 60611, United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago Illinois, 60611, United States
CCOP - Central Illinois
Decatur Illinois, 62526, United States
CCOP - Evanston
Evanston Illinois, 60201, United States
CCOP - Illinois Oncology Research Association
Peoria Illinois, 61602, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
Indiana University Cancer Center
Indianapolis Indiana, 46202, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis Indiana, 46202, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids Iowa, 52403, United States
CCOP - Iowa Oncology Research Association
Des Moines Iowa, 50309, United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City Iowa, 52242, United States
Veterans Affairs Medical Center - Wichita
Wichita Kansas, 67218, United States
MBCCOP - LSU Health Sciences Center
New Orleans Louisiana, 70112, United States
CCOP - Ochsner
New Orleans Louisiana, 70121, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21231, United States
New England Medical Center Hospital
Boston Massachusetts, 02111, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
CCOP - Ann Arbor Regional
Ann Arbor Michigan, 48106, United States
CCOP - Kalamazoo
Kalamazoo Michigan, 49007, United States
CCOP - Duluth
Duluth Minnesota, 55805, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis Minnesota, 55417, United States
University of Minnesota Cancer Center
Minneapolis Minnesota, 55455, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota, 55416, United States
Veterans Affairs Medical Center - Omaha
Omaha Nebraska, 68105, United States
CCOP - Missouri Valley Cancer Consortium
Omaha Nebraska, 68131, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas Nevada, 89106, United States
Veterans Affairs Medical Center - East Orange
East Orange New Jersey, 07018, United States
CCOP - Northern New Jersey
Hackensack New Jersey, 07601, United States
Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
Veterans Affairs Medical Center - Albany
Albany New York, 12208, United States
Albert Einstein Comprehensive Cancer Center
Bronx New York, 10461, United States
MBCCOP-Our Lady of Mercy Cancer Center
Bronx New York, 10466, United States
Veterans Affairs Medical Center - Brooklyn
Brooklyn New York, 11209, United States
Veterans Affairs Medical Center - New York
New York New York, 10010, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York New York, 10016, United States
University of Rochester Cancer Center
Rochester New York, 14642, United States
CCOP - Merit Care Hospital
Fargo North Dakota, 58122, United States
Ireland Cancer Center
Cleveland Ohio, 44106, United States
Veterans Affairs Medical Center - Cleveland
Cleveland Ohio, 44106, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
CCOP - Columbus
Columbus Ohio, 43206, United States
CCOP - Toledo Community Hospital Oncology Program
Toledo Ohio, 43623, United States
CCOP - Sooner State
Tulsa Oklahoma, 74136, United States
CCOP - Geisinger Clinic and Medical Center
Danville Pennsylvania, 17822, United States
Hahnemann University Hospital
Philadelphia Pennsylvania, 19102, United States
University of Pennsylvania Cancer Center
Philadelphia Pennsylvania, 19104, United States
University of Pennsylvania Health Systems
Philadelphia Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
University of Pittsburgh Cancer Institute
Pittsburgh Pennsylvania, 15213, United States
Veterans Affairs Medical Center - Pittsburgh
Pittsburgh Pennsylvania, 15240, United States
CCOP - MainLine Health
Wynnewood Pennsylvania, 19096, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls South Dakota, 57105, United States
Veterans Affairs Medical Center - Nashville
Nashville Tennessee, 37212, United States
Vanderbilt-Ingram Cancer Center
Nashville Tennessee, 37232, United States
Veterans Affairs Medical Center - Madison
Madison Wisconsin, 53705, United States
University of Wisconsin Comprehensive Cancer Center
Madison Wisconsin, 53792, United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield Wisconsin, 54449, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee Wisconsin, 53295, United States
MBCCOP - San Juan
San Juan , 00927, Puerto Rico
Veterans Affairs Medical Center - San Juan
San Juan , 00927, Puerto Rico
Pretoria Academic Hospitals
Pretoria , 0001, South Africa

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 2

Study ID:

NCT00006786

Recruitment Status:

Completed

Sponsor:


Eastern Cooperative Oncology Group

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