Efficacy and Safety Study of Cetuximab or Cetuximab Plus Docetaxel to Treat Prostate Cancer Before Prostatectomy

Phase 2 Terminated 7 enrolled The Methodist Hospital Research Institute Bristol-Myers Squibb · collab Eli Lilly and Company · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to differentiate between the administrations of Cetuximab alone vs. Cetuximab plus Docetaxel in the treatment of non-metastatic prostate cancer before the surgical removal of the prostate.

Timeline

Start: 2007-02
Primary completion: 2008-06
Completion: 2008-08

Outcome

Outcome not reported

Stopped (Enrollment): “lack of patient population - slow accrual”

Publications

Background Prewett M, Rockwell P, Rockwell RF, Giorgio NA, Mendelsohn J, Scher HI, Goldstein NI. The biologic effects of C225, a chimeric monoclonal antibody to the EGFR, on human prostate carcinoma. J Immunother Emphasis Tumor Immunol. 1996 Nov;19(6):419-27. doi: 10.1097/00002371-199611000-00006.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cetuximab	Monoclonal antibody	—	—
Subject	Docetaxel	Small molecule	—	—