NCT00313482

PII Trial of Docetaxel/Prednisone w/Sargramostim for HRPC

A Phase II Trial of Docetaxel/Prednisone in Combination With Sargramostim as Treatment for Hormone-refractory Prostate Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Veeda Oncology · Academic / Other
• Sex: Male
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II, open-label study in male patients with metastatic HRPC. Each cycle will be 21 days (3 weeks). Patients will receive the following drugs: * Docetaxel 75 mg/m2 IV given over 1 hour on Day 1. * Prednisone 5 mg orally twice daily beginning on Day 1 and continuing until disease progression. * Sargramostim 250 mcg/m2 SC on Days 2-15 of each cycle. Patients will be evaluated every 4 cycles (12 weeks) for response using RECIST criteria. PSA response will be evaluated according to the National Cancer Institute (NCI) PSA Working Group Criteria. To evaluate the safety of this drug combination, patients will be evaluated at each clinic visit for adverse events. Toxicities will be assessed per National Cancer Institute (NCI) CTCAE Version 3.0. Those patients achieving stable disease or better will continue therapy. Those patients experiencing progressive disease will be taken off study. Patients will receive a maximum of 10 cycles of treatment.

Conditions

• Hormone Refractory Prostate Cancer

Interventions

Type	Name	Description
DRUG	Sargramostim	250 mcg/m2 SC days 2-15 of each cycle
DRUG	Docetaxel	75 mg/m2 IV over 1 hour on Day 1 of each cycle
DRUG	Prednisone	5 mg orally BID on Day 1 continuously

Timeline

• Start date: 2006-04-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2006-04-12
• Last updated: 2012-05-11

Locations

1 site across 1 country: United States