Oxaliplatin and Bevacizumab (Avastin™) With Either Fluorouracil and Leucovorin or Capecitabine in Treating Patients With Advanced Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring adenocarcinoma of the colon, adenocarcinoma of the rectum, recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the colon or rectum Metastatic or recurrent disease not amenable to potentially curative treatment At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan Histological or cytological confirmation is required for a solitary target lesion No CNS metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 2 times upper limit of normal (ULN) SGPT and SGOT no greater than 3 times ULN Renal Creatinine no greater than 1.5 times ULN Creatinine clearance at least 30 mL/min Cardiovascular No myocardial infarction within the past 6 months No clinical evidence of congestive heart failure No unstable coronary artery disease Pulmonary No interstitial pneumonia No extensive symptomatic fibrosis of the lungs Gastrointestinal Able to tolerate oral medication No lack of physical integrity of the upper gastrointestinal tract No malabsorption syndrome No swallowing difficulties Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study participation No other concurrent serious illness No uncontrolled infection No other concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix or any other cancer for which the patient has been off all therapy and in remission for at least 5 years No peripheral neuropathy No hypersensitivity to any of the study drugs or their ingredients No known dihydropyrimidine dehydrogenase deficiency No other medical or psychiatric disorder that would preclude giving informed consent or complying with study PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent prophylactic hematopoietic growth factor therapy No prior bevacizumab (Avastin™) Chemotherapy At least 6 months since prior adjuvant fluorouracil, leucovorin calcium, and irinotecan No prior oxaliplatin No prior chemotherapy for metastatic or recurrent disease No other concurrent chemotherapy Endocrine therapy Not specified Radiotherapy No concurrent radiotherapy unless for the control of bone pain Surgery Recovered from prior surgery No prior organ allografts Other More than 4 weeks since prior investigational drugs No concurrent iced mouth rinses for the prevention of stomatitis No concurrent cold cap alopecia prevention No concurrent pyridoxine No concurrent sorivudine or chemically-related analogues (e.g., brivudine) No concurrent chronic aspirin, nonsteroidal anti-inflammatory drugs, or warfarin
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer Center
- Arizona Clinical Research Center
- California Cancer Care, Inc.
- Valley Tumor Medical Group
- Cancer and Blood Institute of the Desert
- Rocky Mountain Cancer Centers - Midtown
- Northwestern Connecticut Oncology-Hematology Associates
- Lombardi Cancer Center at Georgetown University Medical Center
- Lynn Regional Cancer Center West
- Florida Cancer Specialists
- Florida Oncology Associates
- Hematology and Oncology Consultants, P.A.
- Hematology Oncology Associates of theTreasure Coast - Port St. Lucie
- Palm Beach Cancer Institute
- Peachtree Hematology and Oncology Consultants, P.C.
- North Idaho Cancer Center
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- Lutheran General Cancer Care Center
- West Suburban Center for Cancer Care
- Saint Anthony Medical Center
- CCOP - Northern Indiana CR Consortium
- Cedar Rapids Oncology Associates
- CCOP - Wichita
- Greater Baltimore Medical Center and Cancer Center
- Jackson Oncology Associates, PLLC
- Veterans Affairs Medical Center - Kansas City
- Deaconess Billings Clinic Cancer Center
- Cooper Cancer Institute at Cooper University Hospital
- Advanced Oncology Associates
- North Shore Hematology/Oncology Associates, P.C.
- Arena Oncology Associates
- St. Vincents Comprehensive Cancer Center
- New York University Medical Center
- New York Medical College
- Duke Comprehensive Cancer Center
- Southeastern Medical Oncology Center
- Physicians East - Quadrangle
- Raleigh Hematology/Oncology Associates, P.A. - Wake Practice
- Hematology Oncology Consultants Inc
- Hematology/Oncology of Salem
- Pennsylvania Oncology Hematology Associates
- Hillman Cancer Center at University of Pittsburgh Cancer Institute
- Charleston Hematology-Oncology, P.A.
- McCleod Cancer and Blood Center
- Memphis Cancer Center
- West Clinic
- Sarah Cannon Cancer Center at Centennial Medical Center
- Lone Star Oncology
- Medical City Dallas Hospital
- South Texas Oncology and Hematology
- Center for Cancer Prevention and Care at Scott and White Clinic
- Medical Consultants