A Phase II Study of Farnesyl Transferase Inhibitor R115777 in Patients With Advanced Non-Small Cell Lung Cancer
- Assess the response rate of patients with recurrent or metastatic non-small cell lung
cancer when treated with tipifarnib.
- Determine the clinical toxicities of this treatment in these patients.
- Assess the overall survival and time to progression of this patient population when
treated with this regimen.
- Evaluate the inhibition of protein farnesylation in vivo and correlate such inhibition
to plasma levels of tipifarnib.
- Evaluate the occurrence of CYP450 polymorphisms and relate these to drug toxicity,
pharmacokinetics, and response to this treatment in this patient population.
OUTLINE: This is a multicenter study.
Patients receive oral tipifarnib twice daily on days 1-21. Treatment repeats every 28 days
in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 5 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 12 months.
Primary Purpose: Treatment
Julian Molina, MD
United States: Food and Drug Administration
|Mayo Clinic||Rochester, Minnesota 55905|
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Mayo Clinic in Florida||Jacksonville, Florida 32224|