RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Leucovorin may increase the effectiveness of fluorouracil by making tumor cells more sensitive to the drug. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of oxaliplatin, fluorouracil, and leucovorin in treating patients who have colorectal cancer.

Condition	Treatment or Intervention	Phase
recurrent colon cancer adenocarcinoma of the rectum Stage IV rectal cancer recurrent rectal cancer stage IV colon cancer adenocarcinoma of the colon	Drug: fluorouracil  Drug: leucovorin calcium  Drug: oxaliplatin	Phase II

Further Study Details: 

OBJECTIVES: I. Evaluate the quantitative and qualitative toxicities of oxaliplatin combined with fluorouracil and leucovorin calcium in patients with advanced adenocarcinoma of the colon or rectum.

PROTOCOL OUTLINE: Patients receive leucovorin calcium IV over 10-20 minutes followed within 10 minutes by fluorouracil IV bolus on days 1, 8, 15, 29, 36, and 43. Patients receive oxaliplatin IV over 2 hours prior to leucovorin calcium and fluorouracil on days 1, 15, 29, and 43. Treatment repeats every 8 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive additional courses upon approval by the sponsor. Patients are followed at 30 days.

PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven advanced adenocarcinoma of the colon or rectum; No prior systemic chemotherapy OR Adjuvant chemotherapy only, completed 6 months prior to study and with subsequent development of recurrent disease
• At least 1 bidimensionally measurable lesion
• No CNS metastases

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: See Disease Characteristics
• Endocrine therapy: Not specified
• Radiotherapy: No prior radiotherapy for malignant disease
• Surgery: Recovered from any prior surgery
• Other: At least 30 days since other prior investigational agent; No other concurrent investigational agents; No concurrent anticancer agents

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-2
• Life expectancy: Greater than 12 weeks
• Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3
• Hepatic: Bilirubin no greater than 2.0 mg/dL (no greater than 5.0 mg/dL if due to intrahepatic biliary obstruction not amenable to biliary decompression, if approved by the protocol investigator); SGOT no greater than 4 times upper limit of normal
• Renal: Creatinine no greater than 1.5 mg/dL
• Cardiovascular: No myocardial infarction within the past 6 months; No congestive heart failure
• Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No neurologic disease; No active or uncontrolled infection; No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix; No medical or psychiatric disorders that would prevent compliance

New York
      NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York,  New York,  10016,  United States

Study chairs or principal investigators

Howard S. Hochster,  Study Chair,  Kaplan Cancer Center   

Study ID Numbers:  CDR0000067321; NYU-9863; NCI-G99-1593; SANOFI-EFC7132
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  December 10, 1999
ClinicalTrials.gov Identifier:  NCT00004102
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08