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Oxaliplatin With Or Without Floxuridine and Leucovorin in Treating Patients With Metastatic Cancer of the Peritoneum Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Oxaliplatin With Or Without Floxuridine and Leucovorin in Treating Patients With Metastatic Cancer of the Peritoneum conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Oxaliplatin With Or Without Floxuridine and Leucovorin in Treating Patients With Metastatic Cancer of the Peritoneum Clinical research trials and Oxaliplatin With Or Without Floxuridine and Leucovorin in Treating Patients With Metastatic Cancer of the Peritoneum health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Oxaliplatin With Or Without Floxuridine and Leucovorin in Treating Patients With Metastatic Cancer of the Peritoneum. Oxaliplatin With Or Without Floxuridine and Leucovorin in Treating Patients With Metastatic Cancer of the Peritoneum Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Oxaliplatin With Or Without Floxuridine and Leucovorin in Treating Patients With Metastatic Cancer of the Peritoneum clinical trial. Human subjects often get the best healthcare available for their Oxaliplatin With Or Without Floxuridine and Leucovorin in Treating Patients With Metastatic Cancer of the Peritoneum condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "O" Clinical Trials Conditions > Oxaliplatin With Or Without Floxuridine and Leucovorin in Treating Patients With Metastatic Cancer of the Peritoneum  Oxaliplatin With Or Without Floxuridine and Leucovorin in Treating Patients With Metastatic Cancer of the Peritoneum
Oxaliplatin With Or Without Floxuridine and Leucovorin in Treating Patients With Metastatic Cancer of the Peritoneum
For Condition: adult primary liver cancer,Gastric Cancer,Colorectal Cancer,ovarian epithelial cancer,Pancreatic Cancer,Colon Cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: 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.
Details: OBJECTIVES: I. 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. II. Determine dose limiting and nondose limiting toxicities and pharmacokinetics of these treatment regimens in this patient population. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - 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 --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) --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: WBC at least 3,000/mm3; Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LeonardSaltz, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000067890; NCI-T99-0107,MSKCC-99100
Study Start Date: April 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005860
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3. Oxaliplatin Plus Irinotecan in Treating Patients With Metastatic Gastrointestinal Cancer
4. Oxaliplatin With Or Without Floxuridine and Leucovorin in Treating Patients With Metastatic Cancer of the Peritoneum
5. BMS-247550 in Treating Patients With Liver or Gallbladder Cancer
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Oxaliplatin With Or Without Floxuridine and Leucovorin in Treating Patients With Metastatic Cancer of the Peritoneum
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