Paclitaxel Combined With Fluorouracil-Uracil and Leucovorin in Treating Patients With Solid Tumors
NCT ID: NCT00009828
Last Updated: 2013-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
1999-12-31
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of paclitaxel combined with fluorouracil-uracil and leucovorin in treating patients who have solid tumors.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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leucovorin calcium
paclitaxel
tegafur-uracil
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Laura A. Pollice
Clinical Research Manager
Principal Investigators
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Chandra P. Belani, MD
Role: STUDY_CHAIR
University of Pittsburgh
Countries
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Other Identifiers
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CDR0000068413
Identifier Type: REGISTRY
Identifier Source: secondary_id
PCI-IRB-990929
Identifier Type: -
Identifier Source: secondary_id
NCI-G00-1903
Identifier Type: -
Identifier Source: secondary_id
98-012
Identifier Type: -
Identifier Source: org_study_id