Spots Global Cancer Trial Database for R115777 in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer

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Trial Identification

Brief Title: R115777 in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer

Official Title: A Phase II Study of Farnesyl Transferase Inhibitor R115777 in Patients With Advanced Non-Small Cell Lung Cancer

Study ID: NCT00005989

Conditions

Lung Cancer

Interventions

tipifarnib

Study Description

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.