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Phase I Study Of Weekly Paclitaxel In Combination With ORZEL (UFT + Leucovorin) For Advanced Non-Hematological Malignancies

Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Study Of Weekly Paclitaxel In Combination With ORZEL (UFT + Leucovorin) For Advanced Non-Hematological Malignancies

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.

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.

Inclusion 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

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)

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Chandra P. Belani, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Pittsburgh


United States: Federal Government

Study ID:




Start Date:

December 1999

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms



University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213