Back to resultsEstramustine, Docetaxel and Zoledronate Treatment in Hormone-Refractory Adenocarcinoma of the Prostate
Primary Purpose
Hormone-Refractory Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Zoledronic acid
Estramustine
Docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for Hormone-Refractory Prostate Cancer focused on measuring Zometa, Prostate Cancer, Metastatic Prostate Cancer
Eligibility 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.
Sites / Locations
- The University of Michigan Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Zoledronate Alone
Docetaxel and Estramustine
Arm Description
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 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.
Outcomes
Primary Outcome Measures
The Percent Increase/Decrease in Bone Markers from Baseline to Cycle 2 Day 2 (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
Percentage of Patients that Respond to Treatment
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
Full Information
NCT ID
NCT00151073
First Posted
September 6, 2005
Last Updated
January 21, 2015
Sponsor
University of Michigan Rogel Cancer Center
Collaborators
Aventis Pharmaceuticals, Novartis
1. Study Identification
Unique Protocol Identification Number
NCT00151073
Brief Title
Estramustine, Docetaxel and Zoledronate Treatment in Hormone-Refractory Adenocarcinoma of the Prostate
Official Title
An Evaluation of Estramustine, Docetaxel and Zoledronate in Patients With Hormone-Refractory Adenocarcinoma of the Prostate
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center
Collaborators
Aventis Pharmaceuticals, Novartis
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hormone-Refractory Prostate Cancer
Keywords
Zometa, Prostate Cancer, Metastatic Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zoledronate Alone
Arm Type
Experimental
Arm Description
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.
Arm Title
Docetaxel and Estramustine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Other Intervention Name(s)
Zometa, Zoledronate
Intervention Type
Drug
Intervention Name(s)
Estramustine
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Primary Outcome Measure Information:
Title
The Percent Increase/Decrease in Bone Markers from Baseline to Cycle 2 Day 2 (Day 23) of Treatment
Description
To assess and compare the effect of zoledronate and docetaxel/estramustine on markers of bone metabolism in patients with hormone-refractory prostate cancer.
Time Frame
Cycle 2 Day 2 of Treatment (Day 23 of Treatment)
Secondary Outcome Measure Information:
Title
Percentage of Patients that Respond to Treatment
Description
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.
Time Frame
Post 3 Cycles (63 days)
Title
The Number of Toxicities Experienced by Patients
Time Frame
30 Days Post Treatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David C. Smith, MD
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Estramustine, Docetaxel and Zoledronate Treatment in Hormone-Refractory Adenocarcinoma of the Prostate
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