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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Prostate Cancer

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Principal Investigator

John D. Hainsworth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

SCRI GU 10

NCT ID:

NCT00193193

Start Date:

August 2000

Completion Date:

February 2007

Related Keywords:

  • Prostate Cancer
  • Carcinoma
  • Prostatic Neoplasms

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