Gefitinib and Everolimus in Treating Patients With Stage IIIB or Stage IV or Recurrent Non-Small Cell Lung Cancer

Phase 1/2 Completed 74 enrolled Memorial Sloan Kettering Cancer Center National Cancer Institute (NCI) · collab

NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Gefitinib and everolimus may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving gefitinib together with everolimus may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects, best way to give, and best dose of giving gefitinib with everolimus and to see how well it works in treating patients with stage IIIB or stage IV or recurrent non-small cell lung cancer.

Timeline

Start: 2004-05
Primary completion: 2010-07
Completion: 2010-07

Outcome

Missed primary endpoint

paper The 13% partial response rate observed did not meet the prespecified response threshold to pursue further study of the combination of gefitinib and everolimus. PMID 20871262 ↗

Publications

Results Price KA, Azzoli CG, Krug LM, Pietanza MC, Rizvi NA, Pao W, Kris MG, Riely GJ, Heelan RT, Arcila ME, Miller VA. Phase II trial of gefitinib and everolimus in advanced non-small cell lung cancer. J Thorac Oncol. 2010 Oct;5(10):1623-9. doi: 10.1097/JTO.0b013e3181ec1531.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Everolimus	Small molecule	5 mg	Oral
Subject	Gefitinib	Small molecule	250 mg	Oral