Hormone-Refractory Prostate Cancer
Conditions
Keywords
Zometa, Prostate Cancer, Metastatic Prostate Cancer
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.
Interventions
Sponsors
Aventis Pharmaceuticals
Novartis
University of Michigan Rogel Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients must have a histologic diagnosis of hormone-refractory adenocarcinoma of the prostate, and hormone refractory disease must be demonstrated by the appearance of new lesions on bone or CT scan and/or a rising PSA value. (No evidence of brain metastasis or untreated spinal cord compression.) Patients on total androgen suppression therapy must undergo nonsteroidal antiandrogen withdrawal and demonstrate a rising PSA 4 weeks after withdrawal from flutamide and 6 weeks after withdrawal from bicalutamide. Patient must not be undergoing current chemotherapy, biologic therapy, other investigational or alternative anti-cancer directed therapy or radiation therapy. Prior radiation therapy must have completed more than 4 weeks prior to registration. Patients may not have received prior taxane-based cytotoxic chemotherapy for hormone refractory disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed