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

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

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

U.S. FDA Resources

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 ]

Enrollment:	56
Study Start Date:	August 2006
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (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

Locations

Spain
Sanofi-aventis
Barcelona, Spain

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

José Taboada

Sanofi-Aventis

More Information

No publications provided

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 10, 2009
ClinicalTrials.gov Identifier:	NCT00705822 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prednisone
Hydrocortisone
Prostatic Diseases
Genital Neoplasms, Male
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Estramustine
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Hormones
Docetaxel

Neoplasms by Site
Therapeutic Uses
Alkylating Agents
Cortisol succinate
Antineoplastic Agents, Hormonal
Genital Diseases, Male
Glucocorticoids
Pharmacologic Actions
Neoplasms
Hydrocortisone acetate
Antineoplastic Agents, Alkylating
Prostatic Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010