Combination of Docetaxel + Estramustine + Hydrocortisone Versus Docetaxel + Prednisone in Patients With Advanced Prostate Cancer
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostatic Neoplasms
Intervention: Docetaxel + Estramustine + Hydrocortisone (Drug); Docetaxel + Prednisone (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
José Taboada, Study Director, Affiliation: Sanofi-Aventis
Overall contact:
Public Registry GMA, Email: publicregistryGMA@sanofi-aventis.com
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 to treatment failure in both strategies To determine the overall and
specific cause survival To evaluate the safety profile To analyze the Quality of Life
Clinical Details
Official title: Combination of Docetaxel + Estramustine + Hydrocortisone Versus Docetaxel + Prednisone in Patients With Advanced Prostate Cancer Who Have Relapse in Biochemistry Whilst Androgenic Blockage
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Response rate over 50% in PSA
Secondary outcome: Time to treatment failureTime to progression Overall and specific cause surveillance Toxicity profile Patients' Quality of Life
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Public Registry GMA, Email: publicregistryGMA@sanofi-aventis.com
Sanofi-Aventis, Barcelona, Spain; Recruiting
Additional Information
Starting date: August 2006
Last updated: December 5, 2008
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