NCT00016107

Combination Chemotherapy Plus Bevacizumab in Treating Patients With Metastatic Prostate Cancer

A Phase II Study Of Estramustine, Docetaxel, And Bevacizumab (IND # 7921, NSC # 704865) In Men With Hormone Refractory Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

Phase II trial to study the effectiveness of combination chemotherapy plus monoclonal antibody therapy in treating patients who have metastatic prostate cancer that has not responded to previous hormone therapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab may stop the growth of cancer cells by stopping blood flow to the tumor. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. To determine time to objective progression, response rate (objective and PSA response) and duration of response in men with hormone refractory prostate cancer treated with estramustine, docetaxel and bevacizumab. II. To determine the toxicity of this regimen in men with hormone refractory prostate cancer. III. To study the relationship of baseline VEGF levels in urine and plasma and changes in these levels to response and duration of response to treatment with bevacizumab, docetaxel and estramustine. OUTLINE: Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV over 1 hour followed by bevacizumab IV over 30-90 minutes on day 2. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed at least every 3 months for 2 years.

Conditions

• Adenocarcinoma of the Prostate
• Hormone-resistant Prostate Cancer
• Recurrent Prostate Cancer
• Stage IV Prostate Cancer

Interventions

Type	Name	Description
DRUG	estramustine phosphate sodium	Given orally
DRUG	docetaxel	Given IV
BIOLOGICAL	bevacizumab	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2001-06-01
• Primary completion: 2007-02-01
• First posted: 2003-06-10
• Last updated: 2013-06-05

Locations

1 site across 1 country: United States