Status:
COMPLETED
Phase II Trial of Abraxane in Front Line Therapy of Hormone Refractory Metastatic Prostate Cancer
Lead Sponsor:
Kaiser Permanente
Collaborating Sponsors:
Celgene Corporation
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
Evaluate the efficacy of Abraxane in first line chemotherapy of patients with hormone refractory metastatic prostate cancer, based on prostate specific antigen (PSA) response
Detailed Description
Taxanes are the most widely tested and effective chemotherapy drugs for hormone refractory prostate cancer. Weekly paclitaxel was reported to produce 25-39% PSA responses in first line and up to 33% i...
Eligibility Criteria
Inclusion
- Histopathologically or cytologically proven adenocarcinoma of the prostate metastatic to the bones or lymph nodes as documented by bone scan or CT scan with evidence of progression despite standard hormonal management (orchiectomy, GNRH agonist, or GNRH antagonist-hormone refractory). No major organ allowed
- No prior chemotherapy
- For patients who have been on anti-androgen therapy, patients must have progressive disease after anti-androgen withdrawal (6 weeks biclutamide or nilutamide, 4 weeks for flutamide).
- PSA progression is defined as rising PSA.
Exclusion
- Active malignancy other than non-melanoma skin cancer within 5 years of enrollment.
- Significant active medical illness which in the opinion of the investigator will preclude treatment.
- Brain metastasis, any non-bone metastasis except lymph node metastasis
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00284752
Start Date
August 1 2005
End Date
December 1 2011
Last Update
October 1 2012
Active Locations (1)
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1
Kaiser Permanente
Vallejo, California, United States, 94589