Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

OBJECTIVES: - 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. - Determine dose limiting and nondose limiting toxicities and pharmacokinetics of these treatment regimens in this patient population. 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.


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 PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 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 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)


NCT ID:

NCT00005860


Primary Contact:

Study Chair
Leonard B. Saltz, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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