Weekly Paclitaxel, Low-Dose Estramustine, and Carboplatin in the Treatment of Hormone Refractory Prostate Carcinoma

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193193
First received: September 12, 2005
Last updated: August 3, 2010
Last verified: July 2010
  Purpose

In this trial we will investigate how this three-drug regimen may be improved, both with respect to efficacy and toxicity, by making some modifications in the dosing and schedule in the treatment of patients with hormone refractory prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: Paclitaxel
Drug: Estramustine
Drug: Carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Phase II Trial of Weekly Paclitaxel, Low-Dose Estramustine, and Carboplatin Administered Either Weekly or Every Four Weeks in the Treatment of Hormone Refractory Prostate Carcinoma

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • Overall response rate

Secondary Outcome Measures:
  • Toxicity
  • Overall survival

Estimated Enrollment: 100
Study Start Date: August 2000
Study Completion Date: February 2007
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Detailed Description:

Upon determination of eligibility, patients will receive:

Paclitaxel + Estramustine + Carboplatin

Patients will receive weekly paclitaxel and low-dose estramustine, in combination with carboplatin administered either weekly r every four weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adenocarcinoma of the prostate not curable with local treatment
  • Disease progression while receiving hormonal therapy
  • Measurable or evaluable disease
  • Previous treatment with a maximum of one prior chemotherapy regimen
  • ECOG performance status 0, 1, or 2.
  • Adequate bone marrow, liver and kidney function
  • Able to comprehend the nature of this study and give written informed consent

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

  • Age < 18 years
  • History of treatment for an invasive malignancy within five years
  • Significant heart disease

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00193193

Sponsors and Collaborators
SCRI Development Innovations, LLC
Bristol-Myers Squibb
Investigators
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00193193     History of Changes
Other Study ID Numbers: SCRI GU 10
Study First Received: September 12, 2005
Last Updated: August 3, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Estramustine
Carboplatin
Paclitaxel
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 17, 2014