PII Trial of Docetaxel/Prednisone w/Sargramostim for HRPC
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|ClinicalTrials.gov Identifier: NCT00313482|
Recruitment Status : Terminated (Low accrual)
First Posted : April 12, 2006
Last Update Posted : May 11, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Hormone Refractory Prostate Cancer||Drug: Sargramostim Drug: Docetaxel Drug: Prednisone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Docetaxel/Prednisone in Combination With Sargramostim as Treatment for Hormone-refractory Prostate Cancer|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||August 2008|
- Drug: Sargramostim
250 mcg/m2 SC days 2-15 of each cycleOther Name: Leukine
- Drug: Docetaxel
75 mg/m2 IV over 1 hour on Day 1 of each cycleOther Name: Taxotere
- Drug: Prednisone
5 mg orally BID on Day 1 continuously
- To evaluate the effects of the combination of docetaxel/prednisone with sargramostim on progression-free survival in chemotherapy-naïve male patients with hormone-refractory prostate cancer (HRPC). [ Time Frame: unk ]
- To evaluate the response (as demonstrated by PSA and/or measurable disease) to the combination of docetaxel/prednisone with sargramostim. [ Time Frame: unk ]
- To evaluate the 1-year and 2-year survival following treatment with the combination of docetaxel/prednisone with sargramostim. [ Time Frame: unk ]
- To evaluate the safety of the combination of docetaxel/prednisone with sargramostim. [ Time Frame: unk ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313482
|United States, Ohio|
|Columbus, Ohio, United States, 43215|
|Principal Investigator:||Evan R Berger, MD||North Shore Hematology Oncology Associates|