Pemetrexed Disodium and Either Cisplatin or Carboplatin in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Recruitment status was Active, not recruiting
RATIONALE: Drugs used in chemotherapy such as pemetrexed disodium, cisplatin, and carboplatin use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether pemetrexed disodium is more effective when combined with cisplatin or carboplatin in treating extensive-stage small cell lung cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of pemetrexed disodium and cisplatin with that of pemetrexed disodium and carboplatin in treating patients who have extensive-stage small cell lung cancer.
Drug: pemetrexed disodium
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Trial Of ALIMTA/Cisplatin And ALIMTA/Carboplatin In Extensive Stage Small Cell Lung Cancer|
|Study Start Date:||April 2003|
- 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 patients.
OUTLINE: This is an open-label, randomized study. Patients are randomized to 1 of 2 treatment arms.
- 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 unacceptable toxicity.
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 this study.
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Diane Prager, MD||Jonsson Comprehensive Cancer Center|