Spots Global Cancer Trial Database for R115777 in Treating Patients With Advanced Solid Tumors

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Trial Identification

Brief Title: R115777 in Treating Patients With Advanced Solid Tumors

Official Title: Phase I Trial of R115777 (NSA 702818) in Advanced Malignant Solid Tumors

Study ID: NCT00025454

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

tipifarnib

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of R115777 in treating patients who have advanced solid tumors.

Detailed Description: OBJECTIVES: * Determine the maximum tolerated dose of R115777 in patients with advanced malignant solid tumors. * Assess the toxicity of this drug in these patients. * Determine, preliminarily, the efficacy of this drug in these patients. * Determine the potential predictors of response in patients treated with drug. OUTLINE: This is a multicenter, dose-escalation study. Patients receive oral R115777 twice daily on weeks 1 and 3. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of R115777 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A minimum of 20 patients will be accrued for this study within 12 months.