A Phase II Trial of R115777, a Farnesyl Transferase Inhibitor, in Combination With Gemcitabine and Cisplatin in Advanced Non-Small Cell Lung Cancer (NSCLC)
I. To describe the response rate in non-small cell lung cancer (NSCLC) patients receiving
combination therapy with R115777, gemcitabine, and cisplatin.
I. To estimate the time to event efficacy variables including: time to progressive disease,
time to treatment failure, time to death of any cause.
II. To estimate the duration of response for responding patients. III. To characterize the
toxicities of R115777, gemcitabine, and cisplatin in this patient population.
I. To evaluate the association between polymorphism expression in candidate genes and
clinical endpoints and toxicity to R115777, gemcitabine, and cisplatin.
OUTLINE: This is a multicenter study.
Patients receive oral tipifarnib twice daily on days 1-14, gemcitabine IV over 30 minutes on
days 1 and 8, and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up
to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients with at least stable disease may continue to receive oral tipifarnib alone twice
daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or
Patients are followed every 6 months for 2 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of confirmed tumor responses, defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart
Ninety-five percent confidence intervals for the true success proportion will be calculated.
Up to 18 weeks (6 courses)
United States: Food and Drug Administration
|Mayo Clinic||Rochester, Minnesota 55905|