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

This study has been completed.

Sponsors and Collaborators: National Cancer Institute (NCI)
Memorial Sloan-Kettering Cancer Center
Information provided by: National Cancer Institute (NCI)

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.

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

MedlinePlus related topics:  Colorectal Cancer;   Liver Cancer;   Ovarian Cancer;   Pancreatic Cancer;   Stomach Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Study of Intraperitoneal Oxaliplatin With or Without Intraperitoneal Floxuridine and Leucovorin Calcium in Patients With Metastatic Cancer Confined to the Peritoneal Cavity

Further Study Details: 

Study start: April 2000

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.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

--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

Location Information


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   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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