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Sponsors and Collaborators: |
Veeda Oncology Bayer |
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Information provided by: | Veeda Oncology |
ClinicalTrials.gov Identifier: | NCT00313482 |
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:
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 | Intervention | Phase |
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Hormone Refractory Prostate Cancer |
Drug: Sargramostim Drug: Docetaxel Drug: Prednisone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Trial of Docetaxel/Prednisone in Combination With Sargramostim as Treatment for Hormone-Refractory Prostate Cancer |
Estimated Enrollment: | 65 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have a history of prior hormone therapy (must fulfill one of the following criteria):
Patient must fulfill one of the following criteria:
Patients must have disease progression defined by the RECIST criteria.
Patients with PSA only disease must have an elevated PSA by Consensus Criteria. -OR-
Exclusion Criteria:
United States, Texas | |
Veeda Oncology | |
Houston, Texas, United States, 77571 |
Principal Investigator: | Evan R Berger, MD | North Shore Hematology Oncology Associates |
Responsible Party: | ION - Clinical Research ( E. Roy Berger, M.D. - Study Principal Investigator ) |
Study ID Numbers: | I-05-011 |
Study First Received: | April 10, 2006 |
Last Updated: | August 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00313482 |
Health Authority: | United States: Institutional Review Board |
Docetaxel Prednisone Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Anti-Inflammatory Agents Neoplasms Neoplasms by Site Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Glucocorticoids Pharmacologic Actions |