Phase II Trial of Abraxane in Front Line Therapy of Hormone Refractory Metastatic Prostate Cancer

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaiser Permanente
• Collaborator: Celgene Corporation
• Treatments: Albumin-Bound Paclitaxel; Hormones; Paclitaxel

Criteria

Inclusion Criteria:

1. 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

2. No prior chemotherapy

3. 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).

4. PSA progression is defined as rising PSA.

Exclusion Criteria:

1. Active malignancy other than non-melanoma skin cancer within 5 years of enrollment.

2. Significant active medical illness which in the opinion of the investigator will preclude treatment.

3. Brain metastasis, any non-bone metastasis except lymph node metastasis