A Randomized Phase II Study of ALIMTA® (Pemetrexed) and GEMZAR® (Gemcitabine) Every 14 Days Versus Pemetrexed and Gemcitabine Every 21 Days in Advanced Non-Small Cell Lung Cancer
- Compare response rates in patients with stage IIIB or IV non-small cell lung cancer
treated with two different treatment schedules of pemetrexed disodium and gemcitabine
- Compare time-to-event efficacy variables in patients treated with these regimens.
- Compare progression-free and overall survival of patients treated with these regimens.
- Determine the overall toxicity of these regimens in these patients.
OUTLINE: This is a multicenter, open-label, randomized study. Patients are stratified
according to disease stage (IIIB vs IV) and ECOG performance status (0 vs 1). Patients are
randomized to 1 of 2 treatment arms.
- Arm I: Patients receive pemetrexed disodium IV over 10 minutes and gemcitabine
hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for
up to 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive pemetrexed disodium IV over 10 minutes and gemcitabine
hydrochloride IV over 30 minutes on day 1. Treatment repeats every 14 days for up to 9
courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 2 years.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients With Confirmed Responses
Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart. > > Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions.
Two consecutive evaluations at least 6 weeks apart (up to 2 years)
Julian Molina, MD, PhD
United States: Food and Drug Administration
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|