GM-CSF for Maintenance of Prostate Cancer for Patients Responding to Taxotere
This trial is designed to investigate the efficacy and safety of GM-CSF used as a maintenance program in patients with androgen-independent prostate cancer (AIPC) who have achieved a maximal response on a taxotere or other chemotherapy schedule.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Pilot Study Investigating the Efficacy and Activity of Single Agent GM-CSF (Leukine) Maintenance Approach in Androgen-independent Prostate Cancer (AIPC) Patients Responding to Taxotere Chemotherapy|
- Time to Disease Progression (TTP) [ Time Frame: time to disease progression (up to 6 months) ] [ Designated as safety issue: No ]The primary end point of this study is to evaluate time to disease progression (TTP). TTP is defined as the time from starting taxotere until there is evidence of progressive disease (PD) as defined below (radiographically and/or biochemically.
- These Include Response Rate (RR), Overall Survival (OS), Toxicity and Safety of Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), and Time to Requiring Additional Systemic Chemotherapy (TTRC) [ Time Frame: time events happen ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2006|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Once patients have finished receiving the chemotherapy and no signs of disease progression they may receive GMCSF as outlined in the protocol
Drug: GM-CSF (Leukine)
250 ug/m2 daily for 2 weeks followed by 2 weeks of rest
Other Name: Leukine
Patients will be treated on this single arm, open label trial until primary end point is met, patient's withdrawal, or investigator's discretion. After achieving a maximal response on taxotere or other chemo schedule they were eligible to enroll in this trial and begin treatment with maintenance GMCSF for 2 weeks followed by 2 weeks of rest. Once progression was documented the patients were taken off study.
|United States, Illinois|
|Oncology Specialists, SC|
|Park Ridge, Illinois, United States, 60068|
|Principal Investigator:||Chadi Nabhan, MD||Oncology Specialists, SC|