oxaliplatin in treating patients with previously treated locally advanced or metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: clinical trial to study the effectiveness of oxaliplatin in treating patients who have locally advanced or metastatic colorectal cancer that has been previously treated.

objectives: * provide oxaliplatin for patients with previously treated locally advanced or metastatic colorectal cancer who have exhausted all approved therapies for colorectal cancer. outline: this is a multicenter, treatment access program study. patients receive oxaliplatin iv over 2 hours on day 1. treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. patients are followed for at least 30 days. projected accrual: approximately one patient per site per month will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is not amenable to surgical resection or other potentially curative therapy * locally advanced or * metastatic disease * patients who progressed on a non-oxaliplatin-containing (control) arm in sanofi-synthelabo second-line regulatory trials or * patients who have exhausted all approved therapies for colorectal cancer (including fluorouracil and irinotecan) and have received at least 2 prior independent/different chemotherapy regimens * documented radiological disease progression after last anticancer treatment patient characteristics: age: * 18 and over performance status: * ecog 0-2 life expectancy: * not specified hematopoietic: * absolute neutrophil count at least 1,500/mm3 * platelet count at least 75,000/mm3 hepatic: * sgot or sgpt no greater than 6 times upper limit of normal (uln) * bilirubin no greater than 2 mg/dl * alkaline phosphatase no greater than 5 times uln renal: * creatinine no greater than 1.5 times uln other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 6 months after study * adequate organ function and medically stable * no known concurrent peripheral neuropathy * absence of deep tendon reflexes as the sole neurologic abnormality is allowed prior concurrent therapy: biologic therapy: * not specified chemotherapy: * see disease characteristics * at least 30 days since prior chemotherapy * no prior oxaliplatin-based chemotherapy * no other concurrent investigational chemotherapy agents endocrine therapy: * not specified radiotherapy: * at least 30 days since prior radiotherapy surgery: * see disease characteristics * at least 30 days since prior major surgical procedure or intervention other: * at least 30 days since other prior anticancer therapy * no other concurrent anticancer agents * no concurrent participation in any other investigational studies

Keywords: stage iii colon cancer stage iv colon cancer stage iii rectal cancer stage iv rectal cancer recurrent colon cancer recurrent rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum