A Randomized Phase II Trial Of ALIMTA/Cisplatin And ALIMTA/Carboplatin In Extensive Stage Small Cell Lung Cancer
- Determine the antitumor activity of pemetrexed disodium and cisplatin or pemetrexed
disodium and carboplatin, as measured by the complete and partial tumor response rate,
in patients with extensive stage small cell lung cancer.
- Determine the duration of response in patients treated with these regimens.
- Determine the time to progression in patients treated with these regimens.
- Determine the survival time in patients treated with these regimens.
- Determine the quantitative and qualitative toxic effects of these regimens in these
OUTLINE: This is an open-label, randomized study. Patients are randomized to 1 of 2
- Arm I: Patients receive pemetrexed disodium IV over 8-15 minutes and cisplatin IV over
1 hour on day 1.
- Arm II: Patients receive pemetrexed disodium as in arm I and carboplatin IV over 1 hour
on day 1.
In both arms, courses repeat every 21 days in the absence of disease progression or
Patients are followed every 6 weeks for 6 months, and then every 12 weeks for 12 months.
PROJECTED ACCRUAL: A total of 34-72 patients (17-36 per treatment arm) will be accrued for
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Diane Prager, MD
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|