Status:

COMPLETED

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

Lead Sponsor:

SCRI Development Innovations, LLC

Collaborating Sponsors:

Bristol-Myers Squibb

Conditions:

Prostate Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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 p...

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 a...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

August 1 2000

Trial Type :

INTERVENTIONAL

End Date :

February 1 2007

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT00193193

Start Date

August 1 2000

End Date

February 1 2007

Last Update

August 4 2010

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