Hormone Therapy and Docetaxel or Hormone Therapy Alone in Treating Patients With Metastatic Prostate Cancer - Full Text View

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
Prostate Cancer	Drug: antiandrogen therapy Drug: docetaxel Drug: goserelin Procedure: orchiectomy	Phase III

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Goserelin Docetaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	Randomized Phase III Trial Comparing an Association of Hormonal Treatment and Docetaxel Versus the Hormonal Treatment Alone in Metastatic Prostate Cancers

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Overall survival at 36 months [ Designated as safety issue: No ]
Progression-free survival (biological progression and/or clinical progression) at 24 months [ Designated as safety issue: No ]
Quality of life [ Designated as safety issue: No ]
Treatment costs [ Designated as safety issue: No ]
Toxicity and tolerance [ Designated as safety issue: Yes ]
Tumor profiles of gene expression as measured by biochips with DNA and tissue microarrays [ Designated as safety issue: No ]

Estimated Enrollment:	378
Study Start Date:	October 2004

Detailed Description:

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 older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104715

Locations

France
C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau	Recruiting
Nimes, France, 30029
Contact: Pierre Costa, MD 33-4-6668-3230 pierre.costa@chu-nimes.fr
Centre Alexis Vautrin	Recruiting
Vandoeuvre-les-Nancy, France, 54511
Contact: Ivan Krakowski, MD 33-83-598-486 i.krakowski@nancy.fnclcc.fr
Centre Antoine Lacassagne	Recruiting
Nice, France, 06189
Contact: Jean Marc Ferrero, MD 33-4-9203-1114 jean-marc.ferrerero@nice.fnclcc.fr
Centre Catherine de Sienne	Recruiting
Nantes, France, 02
Contact: Claude El Kouri 33-2-2827-2166
Centre de Lutte Contre le Cancer Georges-Francois Leclerc	Recruiting
Dijon, France, 21079
Contact: Pierre Fargeot, MD 33-38-073-7506 pfargeot@dijon.frclcc.fr
Centre Eugene Marquis	Recruiting
Rennes, France, 35042
Contact: Brigitte Laguerre 33-2-9925-3000
Centre Hospital Regional Universitaire de Limoges	Recruiting
Limoges, France, 87042
Contact: Jean-Luc Labourey 33-5-5505-6123
Centre Hospitalier de la Cote Basque	Recruiting
Bayonne, France, 64100
Contact: Contact Person 33-5-5944-3535
Centre Hospitalier Departemental	Recruiting
La Roche Sur Yon, France, 85025
Contact: Franck Priou, MD 33-2-5144-6161 frank.priou@chd-vendee.fr
Centre Hospitalier General de Mont de Marsan	Recruiting
Mont-de-Marsan, France, 40000
Contact: Jerome Dauba 33-5-5805-1725
Centre Hospitalier General	Recruiting
Le Mans, France, 72037
Contact: Marie-Aude Coulon 33-2-4343-4364
Centre Hospitalier Regional de Purpan	Recruiting
Toulouse, France, 31059
Contact: Michel Soulie, MD 33-5-6132-2731
Centre Hospitalier Regionale de Vichy	Recruiting
Vichy, France, 03201
Contact: Elhani Khenifar 33-4-7097-3469
Centre Hospitalier Universitaire Bretonneau de Tours	Recruiting
Tours, France, 37044
Contact: Claude Linassier, MD, PhD 33-2-4747-3827 linassier@med.univ-tours.fr
Centre Hospitalier Universitaire Henri Mondor	Recruiting
Creteil, France, 94000
Contact: Jean-Leon Lagrange, MD 33-1-49-814-524 jean-leon.lagrange@hmn.aphp.fr
Centre Leon Berard	Recruiting
Lyon, France, 69008
Contact: Aude Flechon 33-4-78-78-26-45
Centre Paul Papin	Recruiting
Angers, France, 49100
Contact: Remy Delva 33-49-800-918-507
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Recruiting
Montpellier, France, 34298
Contact: Stephane Culine, MD 33-4-6761-3755 stculine@valdorel.fnclcc.fr
Centre Regional Francois Baclesse	Recruiting
Caen, France, 14076
Contact: Florence Joly, MD, PhD 33-02-31-45-50-17 f.joly@baclesse.fr
Centre Rene Huguenin	Recruiting
Saint Cloud, France, 92211
Contact: Alain Goupil 33-1-47-111-515
Polyclinique du Parc	Recruiting
Cholet, France, 49300
Contact: Alain Zanetti 33-2-4163-4200
Clinique D'Occitanie	Recruiting
Muret, France, 31600
Contact: Marion Montastruc, MD 33-5-61-51-88-92
Clinique Du Parc	Recruiting
Toulouse, France, 31078
Contact: Etienne Suc 33-5-6154-9035
Clinique Sainte-Marguerite	Recruiting
Hyeres, France, 83400
Contact: Jean F. Berdah, MD 33-4-9412-5555 jf.berdah@wanadoo.fr
CRLCC Nantes - Atlantique	Recruiting
Nantes-Saint Herblain, France, 44805
Contact: Frederic Rolland, MD 33-2-40-67-99-76 F-rolland@nantes.fnclcc.fr
Hopital Avicenne	Recruiting
Bobigny, France, 93009
Contact: Pierre Saintigny, MD 33-1-4895-5133
Hopital Europeen Georges Pompidou	Recruiting
Paris, France, 75015
Contact: Stephane Oudard, MD, PhD 33-1-56-093-476 stephane.oudard@hop.egp.ap-hop-paris.fr
Hopital Foch	Recruiting
Suresnes, France, 92151
Contact: Contact Person 33-1-4625-2643
Hopital Notre-Dame de Bon Secours	Recruiting
Metz, France, 57038
Contact: Christian Platini, MD 33-3-8755-3554 cplatini@chr-metz-thionville.fr
Hopital Saint Andre	Recruiting
Bordeaux, France, 33075
Contact: Alain Ravaud, MD, PhD 33-5-5679-5808 alain.ravaud@chu-bordeaux.fr
Hopital Saint Joseph	Recruiting
Paris, France, 75674
Contact: Gael Deplanque, MD, MSC, PhD 33-1-4412-3078 gdeplanque@hpsj.fr
Hopital Saint-Louis	Recruiting
Paris, France, 75475
Contact: Contact Person 33-1-42-49-49-49
Hopital Tenon	Recruiting
Paris, France, 75970
Contact: Jean-Pierre Lotz, MD 33-1-5601-6058 jean-pierre.lotz@tnn.ap-hop-paris.fr
Institut Bergonie	Recruiting
Bordeaux, France, 33076
Contact: Contact Person 33-556-333-333
Institut Claudius Regaud	Recruiting
Toulouse, France, 31052
Contact: Christine Chevreau-Dalbianco, MD 33-56-142-4114 chevreau@icr.fnclcc.fr
Institut Curie Hopital	Recruiting
Paris, France, 75248
Contact: Philippe Beuzeboc, MD 33-44-32-4682
Institut Gustave Roussy	Recruiting
Villejuif, France, F-94805
Contact: Karim Fizazi, MD, PhD 33-1-4211-6264 fizazi@igr.fr
Institut Jean Godinot	Recruiting
Reims, France, 51056
Contact: Jean-Christophe Eymard, MD 33-03-2650-4444 jc.eymard@reims.fnclcc.fr
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes	Recruiting
Marseille, France, 13273
Contact: Gwenaelle Gravis, MD 33-4-9122-3740 gravisg@marseille.fnclcc.fr
Polyclinique des Quatre Pavillons	Recruiting
Lormont, France, 33310
Contact: Pierre Guichard, MD 33-5-5780-8489
CHU de la Timone	Recruiting
Marseille, France, 13385
Contact: Marjorie Baciuchka-Palmaro 33-91-385-708

Sponsors and Collaborators

Federation Nationale des Centres de Lutte Contre le Cancer

Investigators

Study Chair:

Gwenaelle Gravis, MD

Institut Paoli-Calmettes

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Gravis G, Fizazi K, Joly F, et al.: Randomized phase III study comparing docetaxel and androgen deprivation therapy (ADT) versus ADT alone in androgen dependent metastatic prostate cancer (GETUG-15/0403): a French national muticentric study sponsored by the French Federation des Centres. [Abstract] American Society of Clinical Oncology 2007 Prostate Cancer Symposium, 22-24 February 2007, Orlando, FL. A-161, 2007.

Study ID Numbers:	CDR0000416096, FRE-FNCLCC-GETUG-15/0403
Study First Received:	March 3, 2005
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00104715 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the prostate
recurrent prostate cancer
stage IV prostate cancer

Study placed in the following topic categories:

Genital Neoplasms, Male
Prostatic Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Goserelin
Urogenital Neoplasms
Genital Diseases, Male

Hormones
Recurrence
Docetaxel
Androgen Antagonists
Adenocarcinoma
Prostatic Neoplasms
Androgens

Additional relevant MeSH terms:

Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male

Pharmacologic Actions
Docetaxel
Neoplasms
Androgen Antagonists
Neoplasms by Site
Therapeutic Uses
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009