Essais en cours en France
hormonothérapie + chimiothérapie versus hormonothérapie seule pour des patients du cancer de la prostate au stade métastatique (version anglaise)


Hormone Therapy and Docetaxel or Hormone Therapy Alone in Treating Patients With Metastatic Prostate Cancer

This study is currently recruiting patients.
Verified by National Cancer Institute (NCI) February 2005
Sponsored by: Federation Nationale des Centres de Lutte Contre le Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov
Identifier: NCT00104715

Purpose

RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as goserelin, may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hormone therapy together with docetaxel may be an effective treatment for prostate cancer. It is not yet known whether giving hormone therapy together with docetaxel is more effective than hormone therapy alone in treating prostate cancer.


PURPOSE: This randomized phase III trial is studying hormone therapy and docetaxel to see how well they work compared to hormone therapy alone in treating patients with metastatic prostate cancer.

Condition Intervention Phase
Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Drug: docetaxel
Drug: goserelin
Procedure: ablative endocrine surgery
Procedure: antiandrogen therapy
Procedure: chemotherapy
Procedure: endocrine therapy
Procedure: hormone therapy
Procedure: orchiectomy
Procedure: releasing factor agonist therapy
Phase III

MedlinePlus related topics: Cancer; Prostate Cancer
Genetics Home Reference related topics: Cancer
Study Type: Interventional
Study Design: Treatment


Official Title: Phase III Randomized Study of Hormonal Therapy and Docetaxel Versus
Hormonal Therapy Alone in Patients With Metastatic Prostate Adenocarcinoma
Further study details as provided by National Cancer Institute (NCI):

OBJECTIVES:
· Compare 36-month overall survival of patients with metastatic prostate
adenocarcinoma treated with hormonal therapy and docetaxel vs hormonal therapy
alone.
· Compare 24-month progression-free survival (biological progression and/or clinical
progression) in patients treated with these regimens.
· Compare the quality of life of patients treated with these regimens.
· Compare costs of these regimens for these patients.
· Compare the tolerability of these regimens in these patients.
· Compare the toxicity profile of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms.
· Arm I: Patients receive hormonal therapy comprising 1 of the following: goserelin
alone OR goserelin and antiandrogen therapy OR surgical castration. Hormonal
therapy continues until the development of hormone resistance. Within 2 months after
initiation of hormonal therapy, patients receive docetaxel IV every 3 weeks for up to 9
courses in the absence of disease progression or unacceptable toxicity.
· Arm II: Patients receive hormonal therapy as in arm I. Quality of life is assessed.

PROJECTED ACCRUAL: A total of 378 patients will be accrued for this study.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria

DISEASE CHARACTERISTICS:
· Histologically confirmed prostate adenocarcinoma
· Metastatic disease
· Measurable or evaluable disease
· No brain metastases

PATIENT CHARACTERISTICS:

Age
· 18 and over

Performance status
· ECOG 0-2

Life expectancy
· At least 3 months

Hematopoietic
· WBC = 2,000/mm^3
· Absolute neutrophil count = 1,000/mm^3
· Platelet count = 100,000/mm^3

Hepatic
· Bilirubin = 1.5 times upper limit of normal (ULN) (2.5 times normal if hepatic
metastases are present)
· AST and ALT = 1.5 times ULN (2.5 times normal if hepatic metastases are present)

Renal
· Creatinine = 150 μmol/L

Cardiovascular
· No symptomatic coronary disease
· No congenital cardiac insufficiency
· No New York Heart Association class III or IV cardiovascular disease
· No other severe cardiovascular disease

Other
· No severe peripheral neuropathy
· No active infection
· No other malignancy within the past 5 years except basal cell skin cancer
· No familial, social, geographical, or psychological situation that would preclude study
compliance and follow-up
· No other serious disease that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy
· Not specified

Chemotherapy
· No prior chemotherapy for metastatic prostate cancer
· Prior chemotherapy allowed provided all of the following are true:
· Chemotherapy was completed > 1 year ago
· Prostate-specific antigen level has remained stable
· No development of metastases within 1 year after completion of chemotherapy

Endocrine therapy
· Prior hormonal therapy within the past 2 months allowed for metastatic prostate
cancer

Radiotherapy
· More than 4 weeks since prior radiotherapy to metastatic sites

Surgery
· No prior surgical castration

Other
· No other concurrent investigational drugs

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00104715

France

Centre Antoine Lacassagne, Nice, 06189, France; Recruiting
J. M. Ferrero, MD 33-4-9203-1114 jean-marc.ferrerero@nice.fnclcc.fr

Centre Eugene Marquis, Rennes, 35042, France; Recruiting
Brigitte Laguerre 33-2-9925-3000

Centre Hospital Regional Universitaire de Limoges, Limoges, 87042, France; Recruiting
Jean-Luc Labourey 33-5-5505-6123

Centre Hospitalier Departemental, La Roche-sur-Yon, 85025, France; Recruiting
Franck Priou 33-02-5144-6161 frank.priou@chd-vendee.fr

Centre Leon Berard, Lyon, 69008, France; Recruiting
Aude Flechon 33-4-78-78-26-45

Centre Medico-Chirurgical Foch, Suresnes, 92151, France; Recruiting
Laurent Mignot, MD 33-146-252-168 ext. 2288

Centre Paul Papin, Angers, 49100, France; Recruiting
Remy Delva 33-49-800-918-507

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle, Montpellier, 34298,
France; Recruiting
Stephane Culine, MD 33-4-6761-3755 stculine@valdorel.fnclcc.fr

Centre Regional Francois Baclesse, Caen, 14076, France; Recruiting
Florence Joly, MD, PhD 33-31-455-000 f.joly@baclesse.fr

Centre Rene Huguenin, Saint Cloud, 92211, France; Recruiting
Alain Goupil 33-1-47-111-515

CHU de la Timone, Marseille, 13385, France; Recruiting
Marjorie Baciuchka-Palmaro 33-91-385-708

Clinique D'Occitanie, Muret, 31600, France; Recruiting
Marion Montastruc, MD 33-5-61-51-88-92

Clinique Du Parc, Toulouse, 31400, France; Recruiting
Igor Latorzeff 33-05-61-36-66-66

Clinique Sainte-Marguerite, Hyeres, 83400, France; Recruiting
Jean F. Berdah, MD 33-4-9412-5555 jf.berdah@wanadoo.fr

CRLCC Nantes - Atlantique, Nantes-Saint Herblain, 44805, France; Recruiting
Frederic Rolland, MD 33-2-40-67-99-76 F-rolland@nantes.fnclcc.fr

Hopital Europeen Georges Pompidou, Paris, 75015, France; Recruiting
Stephane Oudard, MD, PhD 33-1-56-093-476 stephane.oudard@hop.egp.ap-hop-paris.fr

Hopital Notre-Dame de Bon Secours, Metz, 57038, France; Recruiting
Christian Platini, MD 33-3-8755-3554 cplatini@chr-metz-thiouville.rss.fr

Hopital Saint Andre, Bordeaux, 33075, France; Recruiting
Alain Ravaud, MD, PhD 33-556-795-808 alain.ravaud@chu-bordeaux.fr

Institut Claudius Regaud, Toulouse, 31052, France; Recruiting
Christine Chevreau-Dalbianco, MD 33-56-142-4174 chevreau@icr.fnclcc.fr

Institut Curie - Section Medicale, Paris, 75248, France; Recruiting
Philippe Beuzeboc, MD 33-44-32-4682

Institut Gustave Roussy, Villejuif, F-94805, France; Recruiting
Karim Fizazi, MD, PhD 33-1-4211-6264 fizazi@igr.fr

Institut Jean Godinot, Reims, 51056, France; Recruiting
Jean-Christophe Eymard, MD 33-03-2650-4444 jc.eymard@reims.fnclcc.fr

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes, Marseille, 13273, France; Recruiting
Gwenaelle Gravis, MD 33-4-9122-3700 gravisg@marseille.fnclcc.fr

Polyclinique du Parc, Cholet, 49300, France; Recruiting
Alain Zanetti 33-2-4163-4200

Study chairs or principal investigators
Gwenaelle Gravis, MD, Study Chair, Marseille Institute of Cancer - Institut J. Paoli and I.
Calmettes

 

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