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| Trial Name: |
Phase 3 Randomized, Open-Label Study of CG1940 and CG8711 Versus Docetaxel and Prednisone in Patients with Metastatic Hormone-Refractory Prostate Cancer Who Are Chemotherapy-Naïve |
| Trial #: |
G-0029
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Objectives
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To compare the duration of survival between the two treatment arms: GVAX® immunotherapy for prostate cancer or docetaxel chemotherapy |
Key Eligibility Criteria
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Males, greater than 18 years of age
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Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate
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Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy
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Detectable metastases |
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ECOG performance status 0-2 |
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Any Gleason score |
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No prior treatment with chemotherapy for prostate cancer |
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No prior treatment with gene therapy |
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No significant cancer related pain |
Treatment
Patients will be randomized to one of two treatment arms:
ARM 1: Initial cancer immunotherapy treatment is 13 bi-weekly injections over 24 weeks, followed by monthly cancer immunotherapy injections for life or until a new treatment for prostate cancer begins.
ARM 2: Taxotere administered every 21 days and prednisone daily for 9 cycles.
Enrollment Information
Select major eligibility criteria are listed above. For more information call 1.866.679.4904. You may also check clinicaltrials.gov for a current list of locations with open sites. Continue to check this website as trial locations are being added regularly.
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