R115777 in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00005989
- Lead Sponsor
- Mayo Clinic
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Mayo Clinic in Florida
🇺🇸Jacksonville, Florida, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States