Pemetrexed Disodium and Carboplatin in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Phase 2 Completed 50 enrolled Alliance for Clinical Trials in Oncology National Cancer Institute (NCI) · collab

NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving pemetrexed disodium together with carboplatin works in treating patients with extensive-stage small cell lung cancer.

Timeline

Start: 2006-02
Primary completion: 2007-12
Completion: 2009-10

Outcome

Missed primary endpoint

paper On the basis of these results, we had strong evidence that the study would not meet the preset efficacy criteria PMID 20209614 ↗

Publications

Results Chee CE, Jett JR, Bernath AM Jr, Foster NR, Nelson GD, Molina J, Nikcevich DA, Steen PD, Flynn PJ, Rowland KM Jr. Phase 2 trial of pemetrexed disodium and carboplatin in previously untreated extensive-stage small cell lung cancer, N0423. Cancer. 2010 May 15;116(10):2382-9. doi: 10.1002/cncr.24967.
Results Jett JR, Bernath AM, Foster NR, et al.: Phase II trial of pemetrexed (P) and carboplatin (C) in previously untreated extensive stage disease small cell lung cancer (ED-SCLC): A NCCTG Study. [Abstract] J Clin Oncol 26 (Suppl 15): A-8066, 2008.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carboplatin	Small molecule	—	Intravenous
Subject	Pemetrexed	Small molecule	500 mg/m2	Intravenous