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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005860
Recruitment Status : Completed
First Posted : April 2, 2004
Last Update Posted : April 26, 2011
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 or disease Intervention/treatment Phase
Cancer Drug: floxuridine Drug: leucovorin calcium Drug: oxaliplatin Phase 1

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: 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 Start Date : April 2000

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Performance status:

  • ECOG 0-2

Life expectancy:

  • 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


Biologic therapy:

  • Not specified


  • At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered

Endocrine therapy:

  • Not specified


  • At least 4 weeks since prior radiotherapy and recovered


  • See Disease Characteristics


  • No other concurrent investigational agents
  • No concurrent antiretroviral therapy (HAART)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005860

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
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Study Chair: Leonard B. Saltz, MD Memorial Sloan Kettering Cancer Center
Layout table for additonal information Identifier: NCT00005860    
Other Study ID Numbers: CDR0000067890
First Posted: April 2, 2004    Key Record Dates
Last Update Posted: April 26, 2011
Last Verified: May 2002
Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV gastric cancer
recurrent gastric cancer
recurrent pancreatic cancer
recurrent colon cancer
regional neuroblastoma
stage 4S neuroblastoma
recurrent neuroblastoma
regional gastrointestinal carcinoid tumor
metastatic gastrointestinal carcinoid tumor
recurrent gastrointestinal carcinoid tumor
advanced adult primary liver cancer
recurrent adult primary liver cancer
small intestine adenocarcinoma
small intestine lymphoma
small intestine leiomyosarcoma
unresectable gallbladder cancer
recurrent gallbladder cancer
unresectable extrahepatic bile duct cancer
recurrent extrahepatic bile duct cancer
recurrent small intestine cancer
recurrent islet cell carcinoma
WDHA syndrome
pancreatic polypeptide tumor
regional pheochromocytoma
metastatic pheochromocytoma
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antineoplastic Agents
Protective Agents
Vitamin B Complex
Growth Substances
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action