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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005860 |
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 | Intervention | Phase |
---|---|---|
Cancer |
Drug: floxuridine Drug: leucovorin calcium Drug: oxaliplatin |
Phase I |
Study Type: | Interventional |
Study Design: | 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 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed metastatic or unresectable cancer largely confined to the peritoneal cavity
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Leonard B. Saltz, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000067890, MSKCC-99100, NCI-T99-0107 |
Study First Received: | June 2, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005860 |
Health Authority: | United States: Federal Government |
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 gastrinoma 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 insulinoma recurrent islet cell carcinoma WDHA syndrome somatostatinoma pancreatic polypeptide tumor glucagonoma regional pheochromocytoma metastatic pheochromocytoma |
Leiomyosarcoma Pseudomyxoma Peritonei Pancreatic Neoplasms Pancreatic Polypeptide Liver neoplasms Leucovorin Gelatinous ascites Pheochromocytoma Neuroblastoma Liver Neoplasms Oxaliplatin Stomach Neoplasms Neoplasm Metastasis Lymphoma Extragonadal Germ Cell Tumor |
Bile duct cancer, extrahepatic Pseudomyxoma peritonei Floxuridine Carcinoma, Islet Cell Insulinoma Stomach cancer Fallopian Tube Neoplasms Recurrence Carcinoma Gall bladder cancer Carcinoid tumor Calcium, Dietary Gastrinoma Ascites Carcinoid Tumor |
Antimetabolites Antimetabolites, Antineoplastic Vitamin B Complex Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs |
Pharmacologic Actions Neoplastic Processes Neoplasms Pathologic Processes Therapeutic Uses Vitamins Micronutrients |