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Estramustine, Docetaxel and Zoledronate Treatment in Hormone-Refractory Adenocarcinoma of the Prostate

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by University of Michigan.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Aventis Pharmaceuticals
Novartis
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00151073
First received: September 6, 2005
Last updated: January 19, 2006
Last verified: January 2006
History of Changes
  Purpose

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.


Condition Intervention Phase
Hormone-Refractory Prostate Cancer
 Drug: Zometa
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Evaluation of Estramustine, Docetaxel and Zoledronate in Patients With Hormone-Refractory Adenocarcinoma of the Prostate

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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:
  • To determine the response rate, duration of response and time to progression for the combination of estramustine, docetaxel and zoledronate in this population.
  • To determine if cycling therapy based on PSA response is feasible in patients with hormone refractory prostate cancer.
  • To assess the toxicities of this combination.
  • To explore the relationship between markers of bone metabolism and evidence of response to therapy.

Estimated Enrollment: 34
Study Start Date: April 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00151073

Locations
United States, Michigan
The University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Aventis Pharmaceuticals
Novartis
Investigators
Principal Investigator: David C. Smith, MD University of Michigan Cancer Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00151073     History of Changes
Other Study ID Numbers: UMCC 2001-051
Study First Received: September 6, 2005
Last Updated: January 19, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Zometa
Prostate Cancer
Metastatic Prostate Cancer

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Estramustine
Docetaxel
 Hormones
Zoledronic acid
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 16, 2012