Safety and Efficacy Study of of Docetaxel vs Docetaxel Estramustine in Hormone Refractory Prostatic Cancer
Randomized Phase Ii Trial Of Weekly Docetaxel, Estramustine And Prednisone Versus Docetaxel And Prednisone In Patient With Hormone-Resistant Prostate Cancer
1 other identifier
interventional
150
2 countries
19
Brief Summary
we propose to randomize patients with hormone resistant prostate cancer between docetaxel/estramustine/prednisone and docetaxel/prednisone in a phase II study. The principal endpoint will be the efficacy in term of PSA response.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2003
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 9, 2007
CompletedFirst Posted
Study publicly available on registry
October 10, 2007
CompletedOctober 27, 2009
October 1, 2009
October 9, 2007
October 26, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare the efficacy of the association of Docetaxel and Estramustineand Prednisone versus Docetaxel and Prednisone in the treatment of hormone refractory prostate cancer in terms o PSA response
within 30 days after end of treatment
Secondary Outcomes (1)
PSA response Time to PSA progression PSA response duration Event Progression-Free Survival Overall survival Palliative response (Pain) Safety Objective response measurable disease (RECIST)
untill death occurs
Study Arms (2)
A
ACTIVE COMPARATORweekly docetaxel and prednisone
B
ACTIVE COMPARATORweekly docetaxel (35mg/m\&) plus prednisone 10mg a day associated with estramustine form day 1to 5 and 8 to 12
Interventions
140mg caps x3 bid from day 1to 5 and day 8 to 12 of each cycle
Eligibility Criteria
You may qualify if:
- Signed informed consent prior to beginning protocol specific procedures.
- years
- Histologically/cytologically proven prostate adenocarcinoma.
- Documented metastatic prostate adenocarcinoma
- Patients must have received prior hormonal therapy as defined below:
- Castration by orchiectomy and/or LHRH agonists with or without
- Antiandrogens
- Other hormonal agents (e.g., ketoconazole, ...)
- Testosterone level should be \< 50 ng/dl in all patients (castrated level).
- Respect of antiandrogen withdrawal period
- No prior chemotherapy regimen at the exception of estramustine phosphate.
- documented disease progression defined either (i) by PSA increase and/or (ii) imaging:
- Prior radiation therapy (to less or equal than 25% of the bone marrow only) is allowed. At least 4 weeks must have elapsed since the completion of radiation therapy and the patient must have recovered from side effects.
- Prior surgery is allowed. At least 4 weeks must have elapsed since the completion of surgery.
- Life expectancy \> 3 months.
- +2 more criteria
You may not qualify if:
- Prior chemotherapy except estramustine phosphate.(2)
- Prior isotope therapy
- Prior radiotherapy to \>25% of bone marrow
- Prior malignancy except the following: adequately treated basal cell or squamous cell skin cancer, or any other cancer from which the patient has been disease-free for \>5 years.
- Known brain or leptomeningeal involvement.
- Symptomatic peripheral neuropathy \> grade 2
- Other serious illness or medical condition
- Concurrent treatment with other experimental drugs.
- Treatment with any other anti-cancer therapy (except LHRH agonists)
- Treatment with systemic corticosteroids used for reasons other than specified by the protocol must be stopped prior to the administration of docetaxel.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
St Pierre
Ottignies, Brabant Wallon, 1340, Belgium
Notre Dame et Reine Fabiola
Charleroi, Hainaut, 6000, Belgium
RHMS louis caty
Baudour, 7331, Belgium
Clinique Saint Luc
Bouge, 5004, Belgium
CHR Warquignies
Boussu, 7300, Belgium
Az klina
Brasschaat, 2930, Belgium
Parc Léopold
Brussels, 1040, Belgium
Hôpitaux IRIS Sud
Brussels, 1050, Belgium
Cliniques Universitaires St luc
Brussels, 1200, Belgium
Sint Nilolaus
Eupen, 4700, Belgium
Clinique St Joseph
Gilly, 6000, Belgium
Notre Dame de Grâce
Gosselies, 6041, Belgium
CH Jolimont Lobbes
La Louvière, 7100, Belgium
St Joseph
Liège, 4000, Belgium
CHU Ambroise paré
Mons, 7000, Belgium
clinique Sainte Elisabeth
Namur, 5000, Belgium
Notre Dame
Tournai, 7500, Belgium
Clinique Universitaire de Mt Godinne
Yvoir, 5004, Belgium
CHR Luxembourg
Luxembourg, 1210, Luxembourg
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Pascal Machiels, MD PHD
Cliniques Universitaires St Luc
- PRINCIPAL INVESTIGATOR
Joseph Kerger, MD
Clinqiue Universitaire de Mont Godinne
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 9, 2007
First Posted
October 10, 2007
Study Start
December 1, 2003
Study Completion
February 1, 2006
Last Updated
October 27, 2009
Record last verified: 2009-10