Estramustine, Docetaxel and Zoledronate Treatment in Hormone-Refractory Adenocarcinoma of the Prostate
- Conditions
- Hormone-Refractory Prostate Cancer
- Interventions
- Registration Number
- NCT00151073
- Lead Sponsor
- University of Michigan Rogel Cancer Center
- Brief Summary
Purpose: The aim of this clinical trail is to evaluate the effectiveness of Zoledronate (Zometa) combined with Estramustine and Docetaxel (Taxotere) in the treatment of patients with hormone-refractory prostate cancer.
- Detailed Description
Hormone refractory prostate cancer refers to advanced disease in which the patient no longer responds to conventional hormonal treatment. When hormone therapy is no longer successful, chemotherapy is a treatment option. However, current single-agent treatment has shown to have limited benefit. In this clinical trail, investigators are evaluating the effectiveness of Zoledronate(Zometa) combined with Estramustine and Docetaxel (Taxotere) in the treatment of patients with hormone refractory prostate cancer. Zometa is a bisphosphonate, and may reduce or delay skeletal complications caused by bone metastases. Estramustine and Taxotere are chemotherapy drugs that have shown activity in hormone refractory prostate cancer. Eligible patients will be randomized to receive Estramustine and Docetaxel (Taxotere) in combination with Zometa or Zometa given alone.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 28
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Zoledronate Alone Zoledronic acid Zoledronate is given alone for the first cycle. All subsequent cycles consist of Docetaxel (70mg/m\^2) given on day 2, Estramustine (280mg) given orally three times per day on days 1-3, and Zoledronate (4mg) given intravenously on day 2. Zoledronate Alone Docetaxel Zoledronate is given alone for the first cycle. All subsequent cycles consist of Docetaxel (70mg/m\^2) given on day 2, Estramustine (280mg) given orally three times per day on days 1-3, and Zoledronate (4mg) given intravenously on day 2. Docetaxel and Estramustine Zoledronic acid Docetaxel and Estramustine are given for the first cycle of therapy. All subsequent cycles consist of Docetaxel (70mg/m\^2) given on day 2, Estramustine (280mg) given orally three times per day on days 1-3, and Zoledronate (4mg) given intravenously on day 2. Zoledronate Alone Estramustine Zoledronate is given alone for the first cycle. All subsequent cycles consist of Docetaxel (70mg/m\^2) given on day 2, Estramustine (280mg) given orally three times per day on days 1-3, and Zoledronate (4mg) given intravenously on day 2. Docetaxel and Estramustine Docetaxel Docetaxel and Estramustine are given for the first cycle of therapy. All subsequent cycles consist of Docetaxel (70mg/m\^2) given on day 2, Estramustine (280mg) given orally three times per day on days 1-3, and Zoledronate (4mg) given intravenously on day 2. Docetaxel and Estramustine Estramustine Docetaxel and Estramustine are given for the first cycle of therapy. All subsequent cycles consist of Docetaxel (70mg/m\^2) given on day 2, Estramustine (280mg) given orally three times per day on days 1-3, and Zoledronate (4mg) given intravenously on day 2.
- Primary Outcome Measures
Name Time Method The Percent Increase/Decrease in Bone Markers from Baseline to Cycle 2 Day 2 (Day 23) of Treatment Cycle 2 Day 2 of Treatment (Day 23 of Treatment) To assess and compare the effect of zoledronate and docetaxel/estramustine on markers of bone metabolism in patients with hormone-refractory prostate cancer.
- Secondary Outcome Measures
Name Time Method Percentage of Patients that Respond to Treatment Post 3 Cycles (63 days) A decrease in PSA of greater than or equal to 50%, without evidence of progression in the bones, will be considered as response to treatment.
The Number of Toxicities Experienced by Patients 30 Days Post Treatment
Trial Locations
- Locations (1)
The University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States