Combination Chemotherapy In Treating Patients With Advanced Cancer

Study Overview
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Brief Summary
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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 combining gemcitabine, fluorouracil-uracil and leucovorin in treating patients who have advanced cancer that has not responded to previous therapy.

Detailed Description
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OBJECTIVES: Determine the maximum tolerated doses of gemcitabine, fluorouracil-uracil (UFT), and leucovorin calcium in patients with advanced refractory cancer. Assess the toxicity of this combination regimen in this patient population. Evaluate this regimen in terms of response rate, response duration, and overall survival in these patients. OUTLINE: This is a dose escalation study of gemcitabine and fluorouracil-uracil. Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Patients receive oral leucovorin calcium immediately followed by oral fluorouracil-uracil (UFT) three times a day on days 1-21. Courses are repeated every 28 days. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gemcitabine and UFT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Official Title
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Phase I Study of Gemcitabine (Gemzar) and UFT/Leucovorin

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: gemcitabine hydrochloride
* Drug: leucovorin calcium
* Drug: tegafur-uracil


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed malignancy refractory to existing chemotherapy or for which no standard therapy exists Evaluable disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: Greater than 3 months Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 8.0 mg/dL Hepatic: Bilirubin less than 2.0 mg/dL AST less than 3.0 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Other: No active infection requiring antibiotics Not pregnant or nursing Fertile patients must use effective barrier contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks since prior systemic cytotoxic chemotherapy (including fluorouracil) and recovered No prior gemcitabine Endocrine therapy: Prior hormonal therapy allowed No concurrent hormonal contraception Radiotherapy: At least 3 weeks since prior radiotherapy to large areas of active bone marrow and recovered Surgery: Prior major surgery allowed and recovered Other: No prior or concurrent antiviral nucleosides

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gemcitabine hydrochloride|nan|
|Drug: leucovorin calcium|nan|
|Drug: tegafur-uracil|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific