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OpenTrials
Completed

NCT Number: NCT00193193

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

paclitaxel

Drug

Estramustine

Drug

carboplatin

Drug

Primary outcomes

  1. Overall response rate

Secondary outcomes

  1. Toxicity

  2. Overall survival

Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study 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

Important dates

Study start
2000
Primary completion
2003
Study completion
2007
First posted
Sep 19, 2005
Registry last updated
Aug 4, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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