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. PURPOSE: Phase I trial to study the effectiveness of oxaliplatin with or without floxuridine and leucovorin in treating patients who have metastatic cancer of the peritoneum.

Condition	Treatment or Intervention	Phase
Pancreatic Cancer Gastric Cancer Colorectal Cancer adult primary liver cancer ovarian epithelial cancer Colon Cancer	Drug: floxuridine  Drug: leucovorin calcium  Drug: oxaliplatin	Phase I

Further Study Details: 

OBJECTIVES: I. Determine the maximum tolerated dose of intraperitoneal oxaliplatin with or without intraperitoneal floxuridine and leucovorin calcium in patients with metastatic cancer confined to the peritoneal cavity. II. Determine dose limiting and nondose limiting toxicities and pharmacokinetics of these treatment regimens in this patient population.

PROTOCOL OUTLINE: This is a dose escalation study of oxaliplatin. Patients receive intraperitoneal (IP) oxaliplatin over 1 hour on day 1 every 2 weeks for 2 courses. Beginning at course 3, patients receive oxaliplatin with floxuridine and leucovorin calcium IP on day 1 and floxuridine and leucovorin calcium IP alone on days 2 and 3. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients with complete surgical resection of disease receive a total of 6 courses of combination chemotherapy. Cohorts of 3-6 patients receive escalating doses of oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity.

PROJECTED ACCRUAL: A total of 3-40 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically or cytologically confirmed metastatic or unresectable cancer largely confined to the peritoneal cavity; Fully resected and/or electrocauterized metastatic disease involving the peritoneum (stage IV, no residual disease) allowed
• No known brain metastases

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
• Endocrine therapy: Not specified
• Radiotherapy: At least 4 weeks since prior radiotherapy and recovered
• Surgery: See Disease Characteristics
• Other: No other concurrent investigational agents; No concurrent antiretroviral therapy (HAART)

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-2
• Life expectancy: Not specified
• Hematopoietic: WBC at least 3,000/mm3; Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3
• Hepatic: Bilirubin normal; SGOT/SGPT no greater than 2.5 times upper limit of normal
• Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min
• Cardiovascular: No symptomatic congestive heart failure; No unstable angina pectoris; No cardiac arrhythmia
• Other: No history of allergy to platinum compounds or antiemetics that would preclude study; No other uncontrolled illness (e.g., active infection); No evidence of neuropathy; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

Leonard Bruce Saltz,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000067890; MSKCC-99100; NCI-T99-0107
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  June 2, 2000
ClinicalTrials.gov Identifier:  NCT00005860
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08