Oxaliplatin With Or Without Floxuridine and Leucovorin in Treating Patients With Metastatic Cancer of the Peritoneum

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 1

Conditions: Cancer

Treatments: Drug: oxaliplatin; Drug: floxuridine; Drug: leucovorin calcium

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00005860

NCI-T99-0107

MSKCC-99100

CDR0000067890

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)