Combination Chemotherapy In Treating Patients With Advanced Cancer

Barbara Ann Karmanos Cancer Institute36 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

gemcitabine hydrochlorideDRUG

leucovorin calciumDRUG

tegafur-uracilDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Data from ClinicalTrials.gov

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