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Home > "P" Clinical Trials Conditions > Paclitaxel Combined With Fluorouracil-Uracil and Leucovorin in Treating Patients With Solid Tumors  Paclitaxel Combined With Fluorouracil-Uracil and Leucovorin in Treating Patients With Solid Tumors
Paclitaxel Combined With Fluorouracil-Uracil and Leucovorin in Treating Patients With Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , University of Pittsburgh Cancer Institute
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 paclitaxel combined with fluorouracil - uracil and leucovorin in treating patients who have solid tumors.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of weekly paclitaxel when combined with fluorouracil-uracil and leucovorin calcium in patients with solid tumors. II. Determine the side effects and toxicity of this regimen in these patients. PROTOCOL OUTLINE: This is a dose escalation study of paclitaxel. Patients receive paclitaxel IV on days 1, 8, and 15. Patients also receive oral fluorouracil-uracil and leucovorin calcium twice daily on days 2-6, 9-13, and 16-20. Treatment repeats every 4 weeks for up to 6 courses in the absence of progressive disease or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which at least 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 2 months and then for survival. PROJECTED ACCRUAL: Approximately 25-30 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 solid tumor for which no curative or effective therapy is available - No symptomatic or uncontrolled brain or leptomeningeal metastasis; Irradiated brain metastasis allowed if neurological status is stable 4 weeks after radiotherapy --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent immunotherapy; No concurrent colony-stimulating growth factors within 24 hours of fluorouracil-uracil - Chemotherapy: No more than 1 prior regimen of chemotherapy; Prior taxanes and fluorouracil allowed; At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered; No other concurrent chemotherapy - Endocrine therapy: At least 3 weeks since prior hormonal therapy and recovered; No concurrent anti-cancer hormonal agents - Radiotherapy: At least 3 weeks since prior radiotherapy and recovered; Concurrent radiotherapy allowed for palliation of painful bone metastases, pathologic fractures of known lytic disease, or brain lesions - Surgery: Not specified - Other: At least 3 weeks since prior investigational drugs; No concurrent antiarrhythmic medication; No other concurrent investigational therapy; No concurrent halogenated anti-viral agent (e.g., lodenosine, fialuridine, clevudine, emtricitabine, or sorivudine) --Patient Characteristics-- - Age: Over 18 - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: Platelet count at least 100,000/mm3; Absolute neutrophil count at least 1,500/mm3 - Hepatic: SGOT no greater than 1.5 times upper limit of normal (ULN); Bilirubin no greater than ULN; No acute hepatitis - Renal: Not specified - Cardiovascular: No unstable cardiac disease requiring treatment; No cardiac arrhythmia; No new onset crescendo or rest angina; Stable exertional angina allowed - Neurological: No symptomatic peripheral neuropathy greater than grade 1; No significant neurological or psychiatric disorders including psychotic disorders, dementia, or seizures - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 2 weeks following study; No other serious illness or medical condition; No active infection, including septicemia; No severe gastrointestinal bleeding No hypersensitivity to leucovorin calcium or fluorouracil-uracil; No psychological, familial, sociological, or geographical condition that would preclude study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ChandraBelani, Study Chair, University of Pittsburgh Cancer Institute
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213
United States
Additional Information:
Study ID Numbers: CDR0000068413; PCI-IRB-990929,NCI-G00-1903,PCI-98012
Study Start Date: December 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00009828
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. E7389 in Treating Patients With Advanced Solid Tumors
2. Combination Chemotherapy In Treating Patients With Metastatic or Unresectable Solid Tumors
3. Combination Chemotherapy Plus Oblimersen in Treating Patients With Advanced Solid Tumors
4. Chemotherapy in Treating Patients With Advanced Solid Tumors
5. BMS-247550 and Gemcitabine in Treating Patients With Advanced Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
Paclitaxel Combined With Fluorouracil-Uracil and Leucovorin in Treating Patients With Solid Tumors
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