Combination Chemotherapy in Treating Patients With Advanced Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of combining R115777 with gemcitabine in treating patients with advanced cancer.
Unspecified Adult Solid Tumor, Protocol Specific
Drug: gemcitabine hydrochloride
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I, Maximum Tolerated Dose (MTD) Trial to Determine the Safety and Pharmacokinetics of Chronic Oral Administration of Farnesyl Transferase Inhibitor R115777 in Combination With Gemcitabine in Subjects With Advanced Incurable Cancer|
|Study Start Date:||October 1998|
|Study Completion Date:||November 2002|
|Primary Completion Date:||November 2002 (Final data collection date for primary outcome measure)|
- Determine the maximum tolerated dose and dose limiting toxicities of tipifarnib in combination with gemcitabine in patients with advanced cancer.
- Investigate potential pharmacokinetic interactions between tipifarnib and gemcitabine in these patients.
- Determine the efficacy of this regimen in patients with measurable or evaluable disease.
- Evaluate the quality of life of these patients.
OUTLINE: This is a dose-escalation study of tipifarnib.
Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral tipifarnib every 12 hours beginning on day 2. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients each receive escalating doses of tipifarnib until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which fewer than one third of the patients experience dose limiting toxicity.
Quality of life is assessed before treatment, on day 22 of each course, and at the end of treatment.
PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003707
|United States, Texas|
|San Antonio Cancer Institute|
|San Antonio, Texas, United States, 78229-3264|
|Study Chair:||Eric K. Rowinsky, MD||San Antonio Cancer Institute|