drugset / Trial / NCT00734851

Multimodality Phase II Study in Prostate Cancer

NCT00734851 ↗

Phase 2 Terminated 36 enrolled Duke University Pfizer · collabSanofi · collab
NaSingle-groupOpen-labelTreatment

Summary

This is a single arm phase II study of docetaxel, prednisone, and sunitinib systemic therapy followed by salvage external beam radiation therapy for men who have experienced PSA recurrence following initial radical prostatectomy for prostate cancer. The primary aim is the rate of progression-free survival at 2 years as measured by lack of PSA progression and no evidence of disease. We hypothesize that this aggressive initial systemic therapy will improve the long term remission rates for men who are undergoing salvage radiation therapy for PSA recurrence in the absence of metastatic disease.

Timeline

Start
2008-12
Primary completion
2014-09
Completion
2014-11

Outcome

Outcome not reported

Stopped: “Dose Limiting Toxicities”

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 70 mg/m2 —
Subject Sunitinib Small molecule 37.5 mg Oral

Indications