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RATIONALE: Drugs used in chemotherapy such as gemcitabine and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining tipifarnib with combination chemotherapy may kill more tumor cells.
- Determine the response rate of patients with stage IIIB or IV non-small cell lung cancer treated with tipifarnib, gemcitabine, and cisplatin.
- Determine the efficacy of this regimen, in terms of time to disease progression, time to treatment failure, and survival, in these patients.
- Determine the duration of response in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Correlate polymorphism expression in candidate genes with clinical endpoints and toxicity in patients treated with this regimen.
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 unacceptable toxicity.
Patients are followed every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within 5 months.
Masking: Open Label, Primary Purpose: Treatment
cisplatin, gemcitabine hydrochloride, tipifarnib
Mayo Clinic Scottsdale
Published on BioPortfolio: 2014-07-23T21:52:29-0400
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