Oxaliplatin With Or Without Floxuridine And Leucovorin In Treating Patients With Metastatic Cancer Of The Peritoneum

Study Overview

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

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.

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.

Cancer

DRUG: floxuridine
DRUG: leucovorin calcium
DRUG: oxaliplatin

CDR0000067890
MSKCC-99100
NCI-T99-0107

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2000-06-02	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2011-04-23
First Submitted that Met QC Criteria 2004-04-01	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2011-04-26
First Posted (ESTIMATED) 2004-04-02	Results First Posted N/A	Last Verified 2002-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

STUDY_CHAIR: Leonard B. Saltz, MD, Memorial Sloan Kettering Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record