Bortezomib, Fluorouracil, Leucovorin, and Oxaliplatin in Treating Patients With Advanced or Metastatic 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: Histologically confirmed advanced or metastatic colorectal cancer Amenable to first-line treatment with oxaliplatin, fluorouracil, and leucovorin calcium for advanced or metastatic disease No symptomatic or radiologic evidence of brain metastases PATIENT CHARACTERISTICS: Age Over 18 Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 2,000/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if liver metastases are present) AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present) Renal Creatinine ≤ 1.7 mg/dL Cardiovascular No ischemic heart disease within the past 6 months No clinically significant ECG changes Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No baseline neuropathy > grade 1 No other prior or concurrent malignancy except cone-biopsied carcinoma of the cervix or adequately treated basal cell or squamous cell skin cancer No unstable systemic disease No active uncontrolled infection No psychological, familial, sociological, or geographical condition that would preclude study participation No hypersensitivity to bortezomib, boron, or mannitol PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior oxaliplatin No prior chemotherapy for advanced or metastatic disease At least 6 months since prior adjuvant chemotherapy Endocrine therapy Not specified Radiotherapy More than 4 weeks since prior radiotherapy Surgery More than 14 days since prior major surgery
Sites / Locations
- Istituto Nazionale per lo Studio e la Cura dei Tumori
- Centre Hospitalier Universitaire Vaudois
- Leeds Cancer Centre at St. James's University Hospital