Oxaliplatin in Treating Patients With Previously Treated Locally Advanced or Metastatic Colorectal Cancer

Roswell Park Cancer Institute

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Colorectal Cancer

Interventions

oxaliplatinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Roswell Park Cancer Institute

Buffalo, New York, United States

Data from ClinicalTrials.gov

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