R115777 Plus Topotecan in Treating Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00005990|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : November 9, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: tipifarnib Drug: topotecan hydrochloride||Phase 1|
- 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 (Clinical Trial)|
|Official Title:||Phase I and Pharmacokinetic Study of the Farnesyl Transferase Inhibitor, R115777, in Combination With Topotecan|
|Study Start Date :||August 2000|
|Actual Primary Completion Date :||September 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|