R115777 in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have recurrent or metastatic non-small cell lung cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study of Farnesyl Transferase Inhibitor R115777 in Patients With Advanced Non-Small Cell Lung Cancer|
|Study Start Date:||November 2002|
|Study Completion Date:||July 2007|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005989
|United States, Florida|
|Mayo Clinic in Florida|
|Jacksonville, Florida, United States|
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Julian Molina, MD||Mayo Clinic|
|Principal Investigator:||Elizabeth Johnson, MD||Mayo Clinic|