A Randomized Phase II Trial Comparing Two Doses of Pulsed Erlotinib Prechemotherapy (PEP-C) in Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
- Compare the major objective response (complete and partial response) rates in patients
with stage IIIB or IV or recurrent non-small cell lung cancer treated with high- versus
low-dose erlotinib hydrochloride combined with paclitaxel and carboplatin.
- Compare the duration of response, time to progression, and survival of patients treated
with these regimens.
- Characterize and compare the toxicities of these regimens.
- Determine the recommended phase III dose of erlotinib hydrochloride.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to gender. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral high-dose erlotinib hydrochloride on days 1 and 2.
Patients also receive paclitaxel IV over 3 hours followed by carboplatin IV over 30
minutes on day 3.
- Arm II: Patients receive oral low-dose erlotinib hydrochloride, paclitaxel, and
carboplatin as in arm I.
In both arms, treatment repeats every 21 days for 6 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Major objective response rate (complete and partial response)
Charles M. Rudin, MD, PhD
Sidney Kimmel Comprehensive Cancer Center
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|