A Phase II Trial of R115777, a Farnesyl Transferase Inhibitor, in Combination With Gemcitabine and Cisplatin in Advanced Non-Small Cell Lung Cancer (NSCLC)

NCT00055757 Phase 2 COMPLETED

Phase II trial to study the effectiveness of combining tipifarnib with gemcitabine and cisplatin in treating patients who have stage III or stage IV non-small cell lung cancer. 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.

Details

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 2
Status	COMPLETED
Enrolment	48
Start date	2003-10

Conditions

• Stage IIIB Non-small Cell Lung Cancer
• Stage IV Non-small Cell Lung Cancer

Interventions

• tipifarnib
• cisplatin
• gemcitabine hydrochloride
• laboratory biomarker analysis

Primary outcomes

• Proportion of confirmed tumor responses, defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart — Up to 18 weeks (6 courses)
  Ninety-five percent confidence intervals for the true success proportion will be calculated.

Countries

United States