R115777 in Treating Patients With Relapsed 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 relapsed small cell lung cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study to Determine the Antitumor Activity of Farnesyltransferase Inhibitor R115777 in Subjects With Relapsed Small Cell Lung Cancer|
|Study Start Date:||September 1999|
|Primary Completion Date:||May 2000 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the objective response rate (complete or partial) and duration of response of patients with small cell lung cancer who have had at least a partial response to one prior chemotherapy regimen for at least 3 months when treated with R115777. II. Determine the time to disease progression, survival, and quality of life in this patient population treated with this drug. III. Assess the safety of R115777 in this patient population. IV. Assess the presence of ras mutations in relapsed patients with available paraffin blocks.
OUTLINE: This is a multicenter study. Patients receive oral R115777 every 12 hours for 14 consecutive days followed by 7 days of rest. Treatment continues in the absence of unacceptable toxicity or disease progression. Quality of life is assessed at baseline, on day 15 of each course, and at the end of the study.
PROJECTED ACCRUAL: A total of 27-40 patients will be accrued for this study.
|United States, New York|
|Kaplan Cancer Center|
|New York, New York, United States, 10016|
|Study Chair:||Abraham Chachoua, MD||New York University School of Medicine|