drugset / Trial / NCT00216203
Pemetrexed Plus Cetuximab in Patients With Recurrent Non Small Cell Lung Cancer
Phase 1/2
Completed
36 enrolled
Nasser Hanna, M.D.
Bristol-Myers Squibb · collabEli Lilly and Company · collabWalther Cancer Institute · collab
NaSingle-groupOpen-labelTreatment
Summary
Both pemetrexed and cetuximab have single agent activity in NSCLC and non-overlapping toxicity profiles. While 2-drug combination therapy has proven superior to single agent therapy in the first-line setting of NSCLC, no such phase III trials have been reported in the second-line setting. Therefore, the purpose of this study is to determine the feasibility of combining these drugs, assessing the toxicity profile, determining the MTD and evaluating the activity of the combination in an expanded phase II setting. If the combination appears to have promising activity, further evaluation of this regimen may be warranted comparing it to single agent pemetrexed or cetuximab alone.
Timeline
- Start
- 2005-05
- Primary completion
- 2008-12
- Completion
- 2008-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | 250 mg/m2 | Intravenous |
| Subject | Pemetrexed | Small molecule | 500 mg/m2 | — |
| Subject | Pemetrexed | Small molecule | 600 mg/m2 | — |
| Subject | Pemetrexed | Small molecule | 750 mg/m2 | — |
| Subject | Pemetrexed | Small molecule | 900 mg/m2 | — |