Spots Global Cancer Trial Database for Combination Chemotherapy in Treating Patients With Advanced Solid Tumors

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Trial Identification

Brief Title: Combination Chemotherapy in Treating Patients With Advanced Solid Tumors

Official Title: Phase I Study Of Oral Etoposide In Combination With ORZEL (UFT + Leucovorin) For Advanced Non-Hematological Malignancies

Study ID: NCT00009815

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

etoposide

leucovorin calcium

tegafur-uracil

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced solid tumors.

Detailed Description: OBJECTIVES: I. Determine the maximum tolerated dose of etoposide when combined with fixed- dose fluorouracil-uracil plus leucovorin calcium in patients with advanced solid tumors. II. Determine possible side effects and toxicity of this regimen in these patients. OUTLINE: This is a dose escalation study of etoposide. Patients receive oral etoposide daily on days 1-10 and oral fluorouracil-uracil plus oral leucovorin calcium twice a day on days 1-21. Treatment repeats every 28 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of etoposide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity. Patients are followed at 2 months and then periodically for survival. PROJECTED ACCRUAL: Approximately 25-30 patients will be accrued for this study.