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

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

Evaluate the efficacy of Abraxane in first line chemotherapy of patients with hormone refractory metastatic prostate cancer, based on prostate specific antigen (PSA) response

Key facts

Study ID

NCT00284752

Run by

Kaiser Permanente

People needed

56

Starts

2005-08-01

Expected to finish

2011-12-01

Last updated by the study team

2012-10-01

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Kaiser Permanente — Vallejo, California, United States

Full record on ClinicalTrials.gov

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