Expired Study
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Buffalo, New York 14263


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00040820


Primary Contact:

Study Chair
Milind Javle, MD
Roswell Park Cancer Institute


Backup Contact:

N/A


Location Contact:

Buffalo, New York 14263
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 10, 2017

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