Spots Global Cancer Trial Database for Paclitaxel and Bryostatin 1 in Treating Patients With Metastatic Prostate Cancer

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Trial Identification

Brief Title: Paclitaxel and Bryostatin 1 in Treating Patients With Metastatic Prostate Cancer

Official Title: Phase II Study of Weekly Paclitaxel and Bryostatin-1 in Hormone Refractory Prostate Cancer

Study ID: NCT00005028

Conditions

Prostate Cancer

Interventions

bryostatin 1

paclitaxel

Study Description

Brief Summary: Phase II trial to study the effectiveness of combining paclitaxel and bryostatin 1 in treating patients who have metastatic prostate cancer that has not responded to hormone therapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

Detailed Description: OBJECTIVES: I. Determine the onset, duration, and degree of response in patients with hormone-refractory, metastatic adenocarcinoma of the prostate treated with paclitaxel and bryostatin 1. II. Determine the toxicity of this regimen in these patients. III. Determine the overall survival of patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and bryostatin 1 IV over 1 hour on days 2, 9, and 16. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 6 months and then every 3 months thereafter.