R115777 Plus Topotecan in Treating Patients With Advanced Solid Tumors
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.
Unspecified Adult Solid Tumor, Protocol Specific
Drug: topotecan hydrochloride
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I and Pharmacokinetic Study of the Farnesyl Transferase Inhibitor, R115777, in Combination With Topotecan|
|Study Start Date:||August 2000|
|Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005990
|United States, New York|
|NYU Cancer Institute at New York University Medical Center|
|New York, New York, United States, 10016|
|Study Chair:||Howard S. Hochster, MD||New York University School of Medicine|