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Combination of Docetaxel + Estramustine + Hydrocortisone Versus Docetaxel + Prednisone in Patients With Advanced Prostate Cancer

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostatic Neoplasms

Intervention: Docetaxel + Estramustine + Hydrocortisone (Drug); Docetaxel + Prednisone (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
José Taboada, Study Director, Affiliation: Sanofi


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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Response rate over 50% in PSA

Secondary outcome:

Time to treatment failure

Time to progression

Overall and specific cause surveillance

Toxicity profile

Patients' Quality of Life


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Male.


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

Sanofi-Aventis Administrative Office, Barcelona, Spain
Additional Information

Starting date: August 2006
Last updated: November 29, 2010

Page last updated: August 23, 2015

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