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

SCRI Development Innovations

Status and phase

Completed

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: Estramustine

Drug: Paclitaxel

Drug: Carboplatin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00193193

SCRI GU 10

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.