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.

Condition	Treatment or Intervention
recurrent colon cancer adenocarcinoma of the rectum stage III colon cancer stage III rectal cancer Stage IV rectal cancer recurrent rectal cancer stage IV colon cancer adenocarcinoma of the colon	Procedure: chemotherapy  Drug: oxaliplatin

Further Study Details: 

OBJECTIVES: I. Provide oxaliplatin for patients with previously treated locally advanced or metastatic colorectal cancer who have exhausted all approved therapies for colorectal cancer.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

New York
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States

Study chairs or principal investigators

Milind Javle,  Study Chair,  Roswell Park Cancer Institute   

Study ID Numbers:  CDR0000069410; RPCI-DS-0130; NCI-G02-2081; SANOFI-LTS7072B
Record last reviewed:  July 2003
Last Updated:  October 13, 2004
Record first received:  July 8, 2002
ClinicalTrials.gov Identifier:  NCT00040820
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08