Oxaliplatin With Or Without Floxuridine and Leucovorin in Treating Patients With Metastatic Cancer of the Peritoneum
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 01, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer
Intervention: floxuridine (Drug); leucovorin calcium (Drug); oxaliplatin (Drug); chemotherapy (Procedure); intraperitoneal therapy (Procedure)
Phase: Phase 1
Sponsored by: Memorial Sloan-Kettering Cancer Center
Official(s) and/or principal investigator(s):
Leonard B. Saltz, MD, Study Chair, Affiliation: Memorial Sloan-Kettering Cancer Center
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.
A Phase I Study of Intraperitoneal Oxaliplatin Alone and in Combination With Intraperitoneal Floxuridine and Leucovorin in Patients With Advanced Metastatic Cancer Confined to the Peritoneal Cavity
Study design: Interventional, Treatment
* 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.
Minimum age: 18 Years.
* 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
* 18 and over
* ECOG 0-2
* Not specified
* WBC at least 3,000/mm^3
* Absolute neutrophil count at least 1,500/mm^3
* Platelet count at least 100,000/mm^3
* Bilirubin normal
* SGOT/SGPT no greater than 2. 5 times upper limit of normal
* Creatinine normal OR
* Creatinine clearance at least 60 mL/min
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* 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:
* Not specified
* At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
* Not specified
* At least 4 weeks since prior radiotherapy and recovered
* See Disease Characteristics
* No other concurrent investigational agents
* No concurrent antiretroviral therapy (HAART)
Locations and Contacts
Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States
Clinical trial summary from the National Cancer Institute's PDQ® database
Last updated: May 2, 2007