Lapatinib Ditosylate in Treating Patients With a Rising PSA Indicating Recurrent Prostate Cancer

Phase 2 Completed 49 enrolled National Cancer Institute (NCI)

NaSingle-groupOpen-labelTreatment

Summary

This phase II trial studies how well lapatinib ditosylate works in treating patients with a rising prostate-specific antigen (PSA), a protein made by the prostate gland, indicating that prostate cancer has come back after previous treatment. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and may delay or prevent the progression of prostate cancer.

Timeline

Start: 2005-09
Primary completion: 2013-06
Completion: 2013-06

Outcome

Missed primary endpoint

registry analysis (superiority or other test); GW572016 (Lapatinib); PSA response rate 0 (90% CI 0 to 8.2) NCT00103194 ↗

paper Although no PSA responses (primary endpoint) was observed PMID 21784672 ↗

Publications

Results Liu G, Chen YH, Kolesar J, Huang W, Dipaola R, Pins M, Carducci M, Stein M, Bubley GJ, Wilding G. Eastern Cooperative Oncology Group Phase II Trial of lapatinib in men with biochemically relapsed, androgen dependent prostate cancer. Urol Oncol. 2013 Feb;31(2):211-8. doi: 10.1016/j.urolonc.2011.01.002. Epub 2011 Jul 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lapatinib	Small molecule	1500 mg	Oral