VX-710, Doxorubicin, and Vincristine for the Treatment of Patients With Recurrent Small Cell Lung Cancer

Phase 2 Terminated 36 enrolled Vertex Pharmaceuticals Incorporated

Non-randomizedSingle-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy for the treatment of patients who have recurrent small cell lung cancer following treatment.

Timeline

Start: 1998-12
Primary completion: 2001-02
Completion: —

Outcome

Missed primary endpoint

paper Although there were durable responses, criteria were not met to proceed with Stage 2 expansion. PMID 17285598 ↗

Publications

Results Gandhi L, Harding MW, Neubauer M, Langer CJ, Moore M, Ross HJ, Johnson BE, Lynch TJ. A phase II study of the safety and efficacy of the multidrug resistance inhibitor VX-710 combined with doxorubicin and vincristine in patients with recurrent small cell lung cancer. Cancer. 2007 Mar 1;109(5):924-32. doi: 10.1002/cncr.22492.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vincristine	Small molecule	—	Intravenous
Subject	biricodar	Small molecule	—	Intravenous
Background	Doxorubicin	Other / unclassified	—	Intravenous