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
- 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
- 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
PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study.
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Eric K. Rowinsky, MD
San Antonio Cancer Institute
United States: Federal Government
|San Antonio Cancer Institute||San Antonio, Texas 78229-3264|