At a glance
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A Randomized Phase II Study of Intermittent Chemotherapy or Intermittent Chemotherapy With Maintenance GM-CSF in Patients With Previously Untreated Hormone Refractory Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating Docetaxel and Docetaxel and GM-CSF for Prostate Cancer. Completed, enrolled 125 participants across 4 sites.
Detailed Summary
This is a two-arm, randomized Phase II study of intermittent chemotherapy with and without GM-CSF. All patients will receive six 21-day cycles of docetaxel 75 mg/m2 on Day 2 of each cycle and 5 mg prednisone twice a day on Days 1-21. Following six cycles of chemotherapy, eligible subjects will be randomized to no maintenance therapy or to maintenance GM-CSF therapy. The GM-CSF group dose schedule will be 250 mcg/m2 subcutaneous (SQ) daily Days 15-28 every 28 days. Patients in both groups will continue until disease progression at which time GM-CSF will be discontinued and chemotherapy will again be administered.
Study Details
Timeline
Interventions
Docetaxel 75mg/m2 every 21 days
Docetaxel 75mg/m2 every 21 days and GM-CSF 250mcg/m2 SQ days 15-28