Acvanced prostate carcinoma
Conditions
Interventions
Trade Name: Taxotere
Product Name: Taxotere
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Docetaxel
Current Sponsor code: XRP6976J
Concentration unit: mg milli
Sponsors
Aventis Pharma, S.A.
Eligibility
Inclusion criteria
Inclusion criteria: - Histologically confirmed prostate adenocarcinoma - Confirmed prostate adenocarcinoma in biochemistry progression androgens block and demonstrated progression despite cessation of antiandrogen therapy. - Patients must have received prior hormonal therapy. - Castration levels of testosterone (Minor to 50 ng/dL) - Biochemistry relapse. - Adequate bone marrow, Hepatic and Renal function. - Patients must be accessible for treatment and follow-up. - Prior surgery and/or radiation therapy is allowed if at least 4 weeks have elapsed since the completion of radiation therapy and the patient have recovered from side effects. Are the trial subjects under 18? Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Prior cytotoxic chemotherapy (including AMP, Ketoconazole), radio isotopes or other hormonal therapy. - Prior malignancy except any cancer adequately treated from wich the patient has been disease free for 2 years or more. - Symptomatic peripheral neuropathy grade mayor or equal to 2 according to NCIC-CTG criteria. - Concomitant serious illness or medical condition: a) Uncontrolled or severe cardiovascular disease. b) Active uncontrolled infection. c) Active peptic ulcer. d) Unstable diabetes mellitus. - Previous history of tromboembolic events in the last 6 months or active thrombophlebitis. - Medical contraindication for EMP including history to estradiol or nitrogen mustard.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: PSA response rates (PSAWG criteria);Secondary Objective: - Time to Treatment Failure - Progression Free Survival (either biochemical or clinical) - Overall and Cause Specific Survival - Clinical response rates (RECIST) - Safety. Toxicity profile according to NCIC-CTG Criteria - Quality of Life (EORTC QLC-30Q+ prostate questionnaire);Primary end point(s): PSA response rates (PSAWG criteria | — |
Countries
Spain
Outcome results
None listed