Combination of Docetaxel + Estramustine + Hydrocortisone Versus Docetaxel + Prednisone in Patients With Advanced Prostate Cancer - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00705822

Purpose

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

Condition	Intervention	Phase
Prostatic Neoplasms	Drug: Docetaxel + Estramustine + Hydrocortisone Drug: Docetaxel + Prednisone	Phase III

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC Prednisone Docetaxel Estramustine Estramustine phosphate Estramustine phosphate sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Combination of Docetaxel + Estramustine + Hydrocortisone Versus Docetaxel + Prednisone in Patients With Advanced Prostate Cancer Who Have Relapse in Biochemistry Whilst Androgenic Blockage

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Response rate over 50% in PSA [ Time Frame: every 3 weeks up to end of treatment and every month until PSA progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to treatment failure [ Time Frame: from Informed Consent signature up to end of the study ] [ Designated as safety issue: No ]
Time to progression [ Time Frame: from Informed Consent signature up to study end ] [ Designated as safety issue: No ]
Overall and specific cause surveillance [ Time Frame: from Informed Consent signature up to study end ] [ Designated as safety issue: Yes ]
Toxicity profile [ Time Frame: from Informed Consent signature up to study end ] [ Designated as safety issue: Yes ]
Patients' Quality of Life [ Time Frame: Before first cycle, every 2 cycles throughout the treatment period, at the study end and first follow-up visit ] [ Designated as safety issue: No ]

Estimated Enrollment:	172
Study Start Date:	August 2006
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Docetaxel + Estramustine + Hydrocortisone	Drug: Docetaxel + Estramustine + Hydrocortisone Docetaxel iv 80 mg + Oral estramustine-pills 140 mg + Oral hydrocortisone-pills 20 mg. Combination of these 3 drugs every 3 weeks
2: Active Comparator Docetaxel + Prednisone	Drug: Docetaxel + Prednisone Docetaxel iv 80 mg + oral prednisone-pills 5 mg. Combination of these 2 drugs every 3 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705822

Contacts

Contact: Public Registry GMA

publicregistryGMA@sanofi-aventis.com

Locations

Spain
Sanofi-Aventis	Recruiting
Barcelona, Spain

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

José Taboada

Sanofi-Aventis

More Information

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	XRP6976J_3502, EudraCT #: 2004-003885-14
Study First Received:	June 24, 2008
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00705822
Health Authority:	Spain: Spanish Agency of Medicines

Study placed in the following topic categories:

Docetaxel
Prednisone
Hydrocortisone
Cortisol succinate
Prostatic Diseases
Genital Neoplasms, Male

Estramustine
Urogenital Neoplasms
Hydrocortisone acetate
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Glucocorticoids

Hormones
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009