Oxaliplatin With Or Without Floxuridine and Leucovorin in Treating Patients With Metastatic Cancer of the Peritoneum
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| ClinicalTrials.gov Identifier: NCT00005860 |
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Recruitment Status :
Completed
First Posted : April 2, 2004
Last Update Posted : April 26, 2011
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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 |
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.
| 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 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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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
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
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
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 4 weeks since prior radiotherapy and recovered
Surgery:
- See Disease Characteristics
Other:
- No other concurrent investigational agents
- No concurrent antiretroviral therapy (HAART)
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 ClinicalTrials.gov identifier (NCT number): NCT00005860
| 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 |
| ClinicalTrials.gov Identifier: | NCT00005860 |
| Other Study ID Numbers: |
CDR0000067890 MSKCC-99100 NCI-T99-0107 |
| First Posted: | April 2, 2004 Key Record Dates |
| Last Update Posted: | April 26, 2011 |
| Last Verified: | May 2002 |
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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 |
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Neoplasm Metastasis Neoplastic Processes Neoplasms Pathologic Processes Leucovorin Oxaliplatin Floxuridine Calcium Levoleucovorin Calcium-Regulating Hormones and Agents Physiological Effects of Drugs |
Antineoplastic Agents Antidotes Protective Agents Vitamin B Complex Vitamins Micronutrients Nutrients Growth Substances Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |