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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
125
Docetaxel 75mg/m2 every 21 days
Docetaxel 75mg/m2 every 21 days and GM-CSF 250mcg/m2 SQ days 15-28
University of California, San Francisco
San Francisco, California, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Oregon Health and Science University Cancer Institute
Portland, Oregon, United States
University of Washington
Seattle, Washington, United States
Time to Progression
The Kaplan-Meier product limit method with 95% confidence intervals will be used to estimate the median time to disease progression during initial course of randomized treatment
Time frame: Up to 7 years
Overall Survival
The Kaplan-Meier product limit method will be used to estimate the median overall survival
Time frame: Up to 7 years
Number of Participants With PSA Response to Successive Series of Chemotherapy
PSA partial response is defined by at least a 50% decline from PSA value from the baseline measurement to 12 weeks of protocol therapy. The decline must be confirmed by a second PSA value obtained 4 or more weeks later For those patients whose PSA have decreased but has not reached response criteria defined above, progressive disease is defined as 25% increase over the nadir PSA value provided that the increase is at least 5ng/mL and is confirmed.
Time frame: Up to 6 years
Cumulative Duration of Time on and Off Docetaxel-based Therapy
Median percentage of time will be calculated to summarize the total duration of chemotherapy and amount of docetaxel/prednisone administered while the patient is on study. The same results will be tabulated for each. For the on-chemotherapy period: will be estimated from the date of starting protocol therapy; if a patient received docetaxel on day 2 of a cycle, he will be considered to have received a full 21 days on therapy. For the off-chemotherapy period: will be calculated from the date of starting the observation or GM-CSF period to the date of resuming chemotherapy
Time frame: Up to 7 years
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