Trial Comparing Cetuximab With Pemetrexed/Cetuximab Therapy for Non-Small Cell Lung Cancer

NCT00203931 ↗

Phase 2 Terminated 55 enrolled University of Chicago Bristol-Myers Squibb · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to determine in patients with Non Small Cell Lung Cancer refractory to previous chemotherapy whether concomitant treatment with cetuximab and pemetrexed improves progression-free survival compared with cetuximab monotherapy.

Timeline

Start: 2005-03
Primary completion: 2008-11
Completion: 2009-11

Outcome

Missed primary endpoint

Stopped (Enrollment): “Slow accrual and evidence from other studies showing benefit of early initiation of pemetrexed after first-line therapy”

paper progression-free survival (Arm B = 2.3 [1.6, 3.1]; Arm A = 1.6 [0.9, 1.9] months P = 0.11). PMID 24386952 ↗

Publications

Maitland ML, Levine MR, Lacouture ME, Wroblewski KE, Chung CH, Gordon IO, Szeto L, Ratko G, Soltani K, Kozloff MF, Hoffman PC, Salgia R, Carbone DP, Karrison TG, Vokes EE. Evaluation of a novel rash scale and a serum proteomic predictor in a randomized phase II trial of sequential or concurrent cetuximab and pemetrexed in previously treated non-small cell lung cancer. BMC Cancer. 2014 Jan 4;14:5. doi: 10.1186/1471-2407-14-5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cetuximab	Monoclonal antibody	250 mg/m2	—
Subject	Pemetrexed	Small molecule	500 mg/m2	—