Status:
TERMINATED
Combination of Docetaxel + Estramustine + Hydrocortisone Versus Docetaxel + Prednisone in Patients With Advanced Prostate Cancer
Lead Sponsor:
Sanofi
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18-75 years
Phase:
PHASE3
Brief Summary
To compare the efficacy of both strategies (reference treatment: Docetaxel+Prednisone and experimental treatment: Docetaxel+Estramustine+Hydrocortisone) by means of PSA values. To determine the time ...
Eligibility Criteria
Inclusion
- Histological or cytological confirmation of prostate adenocarcinoma
- Advanced prostate carcinoma.
- Previous treatment with hormones
- Levels of testosterone \< 50 ng/dL
- Good hematological, liver and kidney function
- Previous treatment with surgery or radiotherapy, at least 4 weeks since end of treatment is allowed (the patient should have been recovered from any side effects.
Exclusion
- Previous chemotherapy (estramustine included).
- Second line hormonotherapy (oestrogens, gestagens, ketoconazole, ...included)
- Previous treatment with radiotherapy (isotopes) or previous radiotherapy over \> 25% of the marrow
- Any malignant process with a free disease interval under 5 years, exception done to non-melanoma skin cancer.
- Concomitant serious diseases
- Concomitant treatment with any other neoplassic therapy (exception done to LHRH agonists and/or biphosphonates).
- Contraindication for the treatment with estramustine.
- Previous history of pulmonary embolism, thromboembolic disease, previous treatment with anticoagulants (except aspirin), active thrombophlebitis or hypercoagulation.
- Previous history of pulmonary spillage or ascitis.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00705822
Start Date
August 1 2006
End Date
July 1 2009
Last Update
November 30 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sanofi-Aventis Administrative Office
Barcelona, Spain