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Flavopiridol, Oxaliplatin, Fluorouracil, and Leucovorin in Treating Patients With Advanced Solid Tumors Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Flavopiridol, Oxaliplatin, Fluorouracil, and Leucovorin in Treating Patients With Advanced Solid Tumors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Flavopiridol, Oxaliplatin, Fluorouracil, and Leucovorin in Treating Patients With Advanced Solid Tumors Clinical research trials and Flavopiridol, Oxaliplatin, Fluorouracil, and Leucovorin in Treating Patients With Advanced Solid Tumors healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Flavopiridol, Oxaliplatin, Fluorouracil, and Leucovorin in Treating Patients With Advanced Solid Tumors. Flavopiridol, Oxaliplatin, Fluorouracil, and Leucovorin in Treating Patients With Advanced Solid Tumors Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Flavopiridol, Oxaliplatin, Fluorouracil, and Leucovorin in Treating Patients With Advanced Solid Tumors clinical trial. Subjects frequently obtain the most expert healthcare possible for their Flavopiridol, Oxaliplatin, Fluorouracil, and Leucovorin in Treating Patients With Advanced Solid Tumors condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "F" Clinical Trials Conditions > Flavopiridol, Oxaliplatin, Fluorouracil, and Leucovorin in Treating Patients With Advanced Solid Tumors  Flavopiridol, Oxaliplatin, Fluorouracil, and Leucovorin in Treating Patients With Advanced Solid Tumors
Flavopiridol, Oxaliplatin, Fluorouracil, and Leucovorin in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as flavopiridol, oxaliplatin, fluorouracil, and leucovorin, work in different ways to stop tumor cells from dividing so they stop growing or die. Flavopiridol may also make tumor cells more sensitive to chemotherapy. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining flavopiridol with oxaliplatin, fluorouracil, and leucovorin in treating patients who have advanced solid tumors.
Details: OBJECTIVES: Primary - Determine the maximum tolerated dose of flavopiridol when given in combination with oxaliplatin, fluorouracil, and leucovorin calcium in patients with advanced solid tumors. - Determine the pharmacokinetics of this regimen in these patients. - Determine, preliminarily, the therapeutic activity of this regimen in these patients. Secondary - Determine the dose-limiting toxicity and the recommended phase II dose of flavopiridol when administered with this regimen in these patients. - Determine the safety and tolerability of this regimen in these patients. - Correlate p21, p53, and apoptotic markers with response in patients treated with this regimen. OUTLINE: This is a non-randomized, open-label, dose-escalation study of flavopiridol. Patients receive flavopiridol IV over 1 hour, oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 48 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol 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. Once the MTD is determined, the cohort is expanded and an additional 10 patients are treated at that dose. PROJECTED ACCRUAL: A total of 3-46 patients will be accrued for this study within approximately 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed advanced solid tumor - Refractory to standard therapy or no standard therapy exists - Evaluable disease - No known CNS metastases - No primary CNS tumors PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 60-100% Life expectancy - Not specified Hematopoietic - WBC 3,500/mm^3 - Neutrophil count 1,500/mm^3 - Platelet count 100,000/mm^3 Hepatic - Bilirubin 1.5 mg/dL - AST and ALT 2.5 times upper limit of normal (ULN) (5 times ULN for liver metastases) Renal - Creatinine 1.5 mg/dL Cardiovascular - No cardiac arrhythmias within the past 6 months - No congestive heart failure within the past 6 months - No myocardial infarction within the past 6 months - No arterial or venous thrombosis within the past year Other - No peripheral neuropathy > grade 1 - No other medical condition that would preclude study participation - No serious or uncontrolled infection - HIV negative - Not pregnant or nursing - No nursing during and for 2 months after study participation - Negative pregnancy test - Fertile patients must use effective contraception during and for 2 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy - At least 2 weeks since prior immunotherapy Chemotherapy - At least 2 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) - No prior flavopiridol Endocrine therapy - Not specified Radiotherapy - At least 2 weeks since prior radiotherapy Surgery - Not specified Other - Recovered from all prior therapy - No concurrent therapy for thrombosis - Prophylaxis for central lines or deep vein thrombosis allowed - No other concurrent investigational medications - No concurrent vitamins, antioxidants, or herbal preparations and supplements - Concurrent single-tablet multivitamin allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GarySchwartz, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Gary Schwartz 212-639-8324
Additional Information:
Study ID Numbers: CDR0000357606; MSKCC-03146,NCI-6365
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080990
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Paclitaxel Combined With Fluorouracil-Uracil and Leucovorin in Treating Patients With Solid Tumors
2. R115777 in Treating Patients With Advanced Solid Tumors
3. Chemotherapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Solid Tumors
4. Fluorouracil Plus UCN-01 in Treating Patients With Advanced or Refractory Solid Tumors
5. Chemotherapy in Treating Patients With Advanced or Metastatic Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Flavopiridol, Oxaliplatin, Fluorouracil, and Leucovorin in Treating Patients With Advanced Solid Tumors
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