R115777 Plus Topotecan in Treating Patients With Advanced Solid Tumors

NYU Langone Health

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 R115777 plus topotecan in treating patients who have advanced solid tumors.

OBJECTIVES: * Determine the dose-limiting toxic effects of R115777 and topotecan in patients with advanced solid tumors. * Determine the maximum tolerated dose of this regimen in these patients. * Determine pharmacokinetic profiles of topotecan alone and in combination with R115777 in these patients. * Measure the inhibition of ras-farnesylation and topo-1 inhibition in peripheral blood mononuclear cells in these patients when treated with this regimen. * Determine activity of this treatment in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive oral R115777 twice daily on days 2-21 (in the first course only R115777 begins on day 3) and topotecan IV continuously on days 1-21. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of R115777 and topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

tipifarnibDRUG

topotecan hydrochlorideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically confirmed advanced solid tumor not amenable to standard curative therapy PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * At least 6 months Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * SGOT no greater than 5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 5 times ULN * No significant hepatic dysfunction that would preclude study Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 50 mL/min Cardiovascular: * No significant cardiovascular dysfunction that would preclude study Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No malabsorption syndrome, partial or complete bowel obstruction, disease significantly affecting gastrointestinal function, or major resection of the stomach or proximal small bowel * At least 1 week since prior active infection requiring systemic medical therapy * No significant organ system dysfunction (neurologic, endocrine) that would preclude study * No dementia or altered mental status that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No more than 3 prior chemotherapy regimens * At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: * Not specified Radiotherapy: * No more than 25% of bone marrow volume irradiated * No prior pelvic radiation * At least 4 weeks since prior radiotherapy and recovered Surgery: * Not specified

Locations (1)

NYU Cancer Institute at New York University Medical Center

New York, New York, United States

Data from ClinicalTrials.gov

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