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.
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.
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
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There are 71 Locations for this study
Scottsdale Arizona, 85259, United States
Duarte California, 91010, United States
Palo Alto California, 94304, United States
Stanford California, 94305, United States
Denver Colorado, 80209, United States
Wilmington Delaware, 19899, United States
Washington District of Columbia, 20060, United States
Washington District of Columbia, 20307, United States
Gainesville Florida, 32608, United States
Miami Florida, 33125, United States
Tampa Florida, 33612, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Decatur Georgia, 30033, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60611, United States
Decatur Illinois, 62526, United States
Evanston Illinois, 60201, United States
Peoria Illinois, 61602, United States
Urbana Illinois, 61801, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46202, United States
Cedar Rapids Iowa, 52403, United States
Des Moines Iowa, 50309, United States
Iowa City Iowa, 52242, United States
Wichita Kansas, 67218, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70121, United States
Baltimore Maryland, 21231, United States
Boston Massachusetts, 02111, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 48106, United States
Kalamazoo Michigan, 49007, United States
Duluth Minnesota, 55805, United States
Minneapolis Minnesota, 55417, United States
Minneapolis Minnesota, 55455, United States
Rochester Minnesota, 55905, United States
Saint Louis Park Minnesota, 55416, United States
Omaha Nebraska, 68105, United States
Omaha Nebraska, 68131, United States
Las Vegas Nevada, 89106, United States
East Orange New Jersey, 07018, United States
Hackensack New Jersey, 07601, United States
New Brunswick New Jersey, 08901, United States
Albany New York, 12208, United States
Bronx New York, 10461, United States
Bronx New York, 10466, United States
Brooklyn New York, 11209, United States
New York New York, 10010, United States
New York New York, 10016, United States
Rochester New York, 14642, United States
Fargo North Dakota, 58122, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43206, United States
Toledo Ohio, 43623, United States
Tulsa Oklahoma, 74136, United States
Danville Pennsylvania, 17822, United States
Philadelphia Pennsylvania, 19102, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15213, United States
Pittsburgh Pennsylvania, 15240, United States
Wynnewood Pennsylvania, 19096, United States
Sioux Falls South Dakota, 57105, United States
Nashville Tennessee, 37212, United States
Nashville Tennessee, 37232, United States
Madison Wisconsin, 53705, United States
Madison Wisconsin, 53792, United States
Marshfield Wisconsin, 54449, United States
Milwaukee Wisconsin, 53226, United States
Milwaukee Wisconsin, 53295, United States
San Juan , 00927, Puerto Rico
San Juan , 00927, Puerto Rico
Pretoria , 0001, South Africa
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