drugset / Trial / NCT00383331
Pemetrexed and Gemcitabine Every 14 Days Versus Every 21 Days in Advanced Non Small Cell Lung Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is designed to evaluate Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8 every 21 days (Arm A) and Pemetrexed and Gemcitabine Day 1 every 14 days (Arm B) in patients with NSCLC. Each agent and sequence has well demonstrated antitumor activity respectively in patients with locally advanced or metastatic NSCLC. Therefore, it is reasonable to investigate the most optimal schedule for this combination, and which combination is associated with the most anti-tumor activity in the phase II arena.
Timeline
- Start
- 2007-02
- Primary completion
- 2008-01
- Completion
- 2008-01
Outcome
Missed primary endpoint
Stopped (Enrollment): “Trial was stopped early due to low enrollment”
registry analysis (superiority or other test); 21-Day Cycle vs 14-Day Cycle; p = 0.48; Fisher Exact NCT00383331 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | 1250 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1500 mg/m2 | Intravenous |
| Subject | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |