A Phase I Trial of Farnesyltransferase Inhibitor, R115777 (NSC # 702818) and Radiotherapy in Patients With Non-Small Cell Lung Cancer
- Determine the maximum tolerated dose and dose-limiting toxicity of tipifarnib given
concurrently with radiotherapy after induction chemotherapy comprising paclitaxel and
carboplatin and followed by maintenance therapy with tipifarnib in patients with stage
IIIA or IIIB non-small cell lung cancer.
- Determine the tumor response at 3 months in patients treated with this regimen.
OUTLINE: This is multicenter, dose-escalation study of tipifarnib.
Patients receive induction chemotherapy comprising carboplatin IV over 30 minutes on day 1
and paclitaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for 2
Beginning 4-6 weeks after the completion of induction chemotherapy, patients receive oral
tipifarnib twice daily for 7 weeks. Patients undergo radiotherapy once daily 5 days a week
for 7 weeks beginning 3 days after the start of tipifarnib. After completion of
radiotherapy, patients receive oral tipifarnib twice daily for 4 days and then once daily
for 4 days.
Cohorts of 3-6 patients receive escalating doses of tipifarnib while receiving radiotherapy
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting
Beginning 4-6 weeks after the completion of radiotherapy and tipifarnib, patients receive
maintenance therapy comprising oral tipifarnib twice daily on days 1-21. Maintenance therapy
repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3, 6, and 12 months.
PROJECTED ACCRUAL: Approximately 9-12 patients will be accrued for this study within 1 year.
Primary Purpose: Treatment
Stephen Michael Hahn, MD
Abramson Cancer Center of the University of Pennsylvania
United States: Food and Drug Administration
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|