Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Must not be eligible for Inter-group, Cooperative Group, or local clinical trials of higher priority Histologically or cytologically confirmed colorectal adenocarcinoma Locally advanced or metastatic Not curable by surgery or amenable to radiation therapy with curative intent Site of primary lesion must be or have been in the large bowel, as confirmed endoscopically, radiologically, or surgically No separate histological or cytological confirmation of metastatic disease is required for patients with a history of colorectal cancer treated by surgical resection who develop radiological or clinical evidence of metastatic cancer unless: More than 5 years has elapsed since prior primary surgery and the development of metastatic disease OR Primary cancer was a Duke's A or B1 lesion Measurable or evaluable disease No prior chemotherapy for advanced colorectal cancer Prior adjuvant therapy allowed for resected stage II, III, or IV disease with any regimen containing fluorouracil with or without irinotecan or with immunotherapy, provided recurrent disease has been documented PATIENT CHARACTERISTICS: Age: 15 and over Performance status: ECOG 0-2 OR Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9 g/dL (transfusion allowed) Hepatic: Bilirubin no greater than 1.5 mg/dL (regardless of liver involvement secondary to tumor) AST less than 5 times upper limit of normal (ULN) Alkaline phosphatase less than 5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No uncontrolled high blood pressure No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No myocardial infarction within the past 6 months No New York Heart Association class III-IV cardiac disease Pulmonary: No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung No pleural effusion or ascites that causes respiratory compromise (i.e., dyspnea grade 2 or greater) Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of allergic reactions to compounds of similar chemical or biologic composition to platinum agents or oxaliplatin as well as other study agents No neuropathy grade 2 or greater, regardless of causality No HIV-positive patients receiving combination anti-retroviral therapy No ongoing or active infection No uncontrolled concurrent illness No psychiatric or social situations that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No concurrent sargramostim Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior major radiotherapy (e.g., chest or bone palliative radiotherapy) Surgery: See Disease Characteristics At least 4 weeks since prior major surgery (e.g., laparotomy) At least 2 weeks since prior minor surgery Insertion of a vascular access device is not considered major or minor surgery Other: Recovered from effects of prior treatment No other concurrent investigational agents No oral cryotherapy on day 1 of each course
Sites / Locations
- Anchorage Oncology Centre
- Mayo Clinic Scottsdale
- University of California San Diego Cancer Center
- Yale Comprehensive Cancer Center
- Mayo Clinic
- Atlanta Cancer Care
- Cancer Center of Kansas - Wichita
- Louisiana State University School of Medicine
- Cancer Therapy Evaluation Program
- Mayo Clinic Cancer Center
- St. Vincent Hospital and Health Center
- Southern Nevada Cancer Research Foundation
- Cancer Institute of New Jersey
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
- Lineberger Comprehensive Cancer Center, UNC
- Ireland Cancer Center
- Fox Chase Cancer Center
- Huntsman Cancer Institute
- Virginia Mason Medical Center