Axitinib Before Surgery in Treating Patients With High-Risk Prostate Cancer

Phase 2 Completed 11 enrolled City of Hope Medical Center National Cancer Institute (NCI) · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase II trial studies how well axitinib works in treating patients with high-risk prostate cancer before undergoing surgery. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving axitinib before surgery may make the tumor smaller and reduce the amount of normal cells that have to be removed

Timeline

Start: 2011-10-28
Primary completion: 2013-10-09
Completion: 2013-10-09

Outcome

Missed primary endpoint

registry analysis (other test); Arm I (Axitinib Followed by Surgery) vs Arm II (Surgery); p >0.05; t-test, 2 sided NCT01385059 ↗

paper While preoperative axitinib was safe and well tolerated, there was no sign of clinical activity or VEGFR1 downregulation. PMID 26450920 ↗

Publications

Pal SK, Vuong W, Zhang W, Deng J, Liu X, Carmichael C, Ruel N, Pinnamaneni M, Twardowski P, Lau C, Yu H, Figlin RA, Agarwal N, Jones JO. Clinical and Translational Assessment of VEGFR1 as a Mediator of the Premetastatic Niche in High-Risk Localized Prostate Cancer. Mol Cancer Ther. 2015 Dec;14(12):2896-900. doi: 10.1158/1535-7163.MCT-15-0367. Epub 2015 Oct 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Axitinib	Small molecule	—	Oral