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Feasibility of a Chemotherapy With Docetaxel-Prednisone for Castration-resistant Metastatic Prostate Cancer Elderly Patients

Information source: UNICANCER
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: Docetaxel every 3 weeks + Prednisone (Drug); Docetaxel weekly+ Prednisone (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: UNICANCER

Official(s) and/or principal investigator(s):
Loic Mourey, Principal Investigator, Affiliation: Institut Claudius Regaud

Overall contact:
Christine Orsini, Phone: +, Email: c-orsini@unicancer.fr


The objective of this study is to evaluate the feasibility of two different chemotherapy protocols with adjusted doses for patients aged 75 and over who often have medical problems other than prostate cancer. Patient will receive Docetaxel either every 3 weeks or weekly. In both cases, chemotherapy is combined with prednisone. The protocol will be considered feasible when patient will receive 6 cycles of chemotherapy (1 cycle = 3 weeks). Additionally to this primary objective, efficacy will also be evaluated for both protocols as well as tolerance to treatment, quality of life and evolution of geriatric data.

Clinical Details

Official title: Randomized Phase II Study Evaluating the Feasibility of a Chemotherapy With Docetaxel-Prednisone in a Weekly Schedule or Every 3 Weeks, for Castration-resistant Metastatic Prostate Cancer Elderly Patients (>=75), "Vulnerable" or "Frail" , as Defined by the Criteria of the International Society of Geriatric Oncology (SIOG)

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Feasibility of 2 different protocols of Docetaxel chemotherapy

Secondary outcome:

Overall Survival

Geriatric evaluation

Number of patients with Adverse Events

Quality of Life

Vital signs measurement

Prostate-specific antigen (PSA) measurements

Detailed description: Standard management of castration-resistant metastatic prostate cancer is represented by chemotherapy with Docetaxel 75 mg/m² every 3 weeks combined with Prednisone since a symptomatic and overall survival benefit was demonstrated. Although this benefit is independent of age in the study by Tannock (cut-off: 69), it does not seem possible to extrapolate these results, obtained in a selected population, to the majority of patients we encounter in daily practice, >= 75 years old and / or unfit. Retrospective studies have shown that chemotherapy was feasible, at standard or adapted doses in an unselected elderly population with good results in terms of tolerance and efficacy over symptoms. Our study aims to evaluate prospectively the feasibility of a chemotherapy with Docetaxel/Prednisone administered every 3 weeks (60 mg / m² at D1C1 then 70 mg / m² at D1 for subsequent cycles if tolerance is good) or weekly (35mg / m² at D1 and D8 with Day 1 = Day 21) to patients >= 75 years old, evaluated by comprehensive geriatric assessment, belonging to group 2 "vulnerable" or to group 3 "frail" of the classification proposed by the International Society of Geriatric Oncology (SIOG). Feasibility is defined as the possibility for a patient to receive 6 cycles of chemotherapy without withdrawal. Reasons for study withdrawal were defined by the GERICO Group and are the followings:

- stop or delay of chemotherapy > 2 weeks

- Necessity to reduce the dose of chemotherapy > 25 %

- febrile neutropenia or non-haematological grade 3 toxicity (except alopecia) according

to NCI-CTCAE V4. 0.

- Geriatric criterion (Activity of Daily Living (ADL) decrease >= 2 points)

The statistical methodology used is a double randomized phase II after stratification according to the SIOG criteria, based on a Simon Optimum plan. A pharmacokinetic / pharmacodynamic study is associated to our project, based on a method of population pharmacokinetic. The aim is to highlight predictors of the haematological tolerance of this chemotherapy by evaluating clinical, geriatric and biological parameters. The results of this study will support the terms of prescription of chemotherapy, in patients aged 75 and over, classified as "vulnerable" or "frail" regarding SIOG criteria, with defined geriatric assessment.


Minimum age: 75 Years. Maximum age: N/A. Gender(s): Male.


Inclusion Criteria:

- Age >= 75

- Histologically proven prostate adenocarcinoma

- Metastatic disease, not pre-treated with chemotherapy refractory to castration

- Hormone refractory prostate cancer is defined as follows:

- Patients with documented testosterone castration (<0. 50 ng / ml)

- Patient who received prior hormonal therapy (either orchidectomy or Luteinizing

hormone-releasing hormone (LHRH) agonist alone or combined with an anti-androgen)

- Patients should continue primary androgen suppression by LHRH agonist (in case

of non-surgical castration)

- For patients treated with anti-androgens prior to inclusion, a wash-out period

is required (4 weeks for flutamide and nilutamide, 6 weeks for other products) as well as measured progression after anti-androgen discontinuation.

- Progressive disease under hormonotherapy, with progression defined by

Increase of PSA level (two consecutive increases of PSA compared to baseline with a minimum of one week between both measurements) OR emergence of a new lesion OR measurable progressive disease (increase of a previous measurable lesion >= 25% in cross section) OR progressive bone metastases (defined only by the appearance of a new lesion on bone scan) OR progressive symptoms (defined as cancer pain Grade 2 according to the NCI-CTC V4. 0, despite level 2 analgesics intake).

- Patients of Groups 2 and 3 [ "vulnerable" and "frail"] of SIOG classification

- WHO Performance Status (PS) >= 3

- PSA >= 5 ng / ml

- Neutrophils >= 2. 109 /L

- Platelets >= 100. 109/L

- Haemoglobin ≥ 9 g/dl

- Bilirubin and SGOT / SGPT <1. 5 x ULN (<= 2. 5 x ULN if hepatic metastasis)

- creatinine <= 2. 5 x ULN

- In case of previous palliative or analgesic radiotherapy, a minimum of 14 days must

have elapsed between end of radiotherapy and inclusion into the study

- Previous treatment with bisphosphonates should be continued without change during the

study treatment and can not be initiated either within 28 days prior to study entry or during the study

- Signed informed consent by patients, according to local regulations

Exclusion Criteria:

- "healthy" or "terminal illness" Groups according to the recommendations of

International Society of Geriatric Oncology (SIOG)

- Concomitant or previous malignancy within 5 years prior the study (except basal or

squamous in situ cell skin carcinoma)

- Presence of brain metastasis symptoms

- Prior treatment by intravenous radiopharmaceutical agent (e. g. Strontium 89, Samarium

lexidronam) within 2 months before study entry

- Initiation of a bisphosphonate therapy within 28 days prior to randomisation

- Any concomitant anticancer treatment (radiotherapy, radiopharmaceutical agent,


- Patients with uncontrolled infection

- Patients with peripheral neuropathy of grade> 1

- Patients medically unstable (e. g. unstable diabetes, uncontrolled hypertension or

decompensated heart failure or myocardial infarct within 3 months)

- Gastro duodenal active ulcer

- Hypersensitivity to study drugs

- Treatment with any experimental drug within 30 days prior to or during the study

- Psychological, familial, sociological or geographical location conditions which do

not allow medical monitoring and compliance with study protocol.

- Patients protected by the law or patients placed under protective supervision of


Locations and Contacts

Christine Orsini, Phone: +, Email: c-orsini@unicancer.fr

Clinique Claude Bernard, Albi 81000, France; Recruiting
Philippe HOUYAU, Dr, Email: philippe.houyau@claude-bernard-albi.com
Philippe HOUYAU, Principal Investigator

CHI Annemasse-Bonneville, Ambilly 74100, France; Not yet recruiting
Carol ALLIOT, Phone: 04 50 87 40 37, Email: calliot@chi-annemasse-bonneville.fr
Carol ALLIOT, Principal Investigator

Centre Paul Papin, Angers 49933, France; Recruiting
Sophie ABADIE, Email: sophie.abadie-lacourtoisie@ico.unicancer.fr
Sophie ABADIE, Principal Investigator

CH de Blois, Blois 41016, France; Not yet recruiting
Charles-Emmanuel GEFFROY, Phone: 02 54 55 63 95, Email: cegeffroy@ch-blois.fr
Charles-Emmanuel GEFFROY, Principal Investigator

Institut Bergonie, Bordeaux Cedex 33076, France; Recruiting
Nadine HOUEDE, Dr, Email: houede@bergonie.org
Nadine HOUEDE, Principal Investigator

Centre Francois Baclesse, Caen 14076, France; Recruiting
Emmanuel SEVIN, Dr, Email: e.sevin@baclesse.fr
Emmanuel SEVIN, Principal Investigator

CH Intercommunal, Castres 81108, France; Recruiting
Corinne SARDA, Email: c-sarda@chic-cm.fr
Corinne SARDA, Principal Investigator

Centre Hospitalier de Chambery, Chambery 73011, France; Not yet recruiting
Armelle DUFRESNES, Dr, Email: a.dufresne@hotmail.com
Armelle DUFRESNES, Principal Investigator

Centre Jean Perrin, Clermont-ferrand 63011, France; Recruiting
Hakim MAHAMMEDI, Phone: 04 73 27 80 80, Email: hakim.mahammedi@cjp.fr
Hakim MAHAMMEDI, Principal Investigator

Clinique Sainte Marguerite, Hyeres 83400, France; Recruiting
Jean-François BERDAH
Jean-françois BERDAH, Principal Investigator

Chd Vendee, La Roche Sur Yon 85925, France; Recruiting
Frank PRIOU, Dr, Email: frank.priou@chd-vendee.fr
Frank Priou, Principal Investigator

Clinique Hartmann, Levallois-perret 92300, France; Recruiting
Jean-Michel VANNETZEL, Dr, Email: jmvannetzel@i-o-h.org
Jean-Michel VANNETZEL, Principal Investigator

Centre Oscar Lambret, Lille 59020, France; Not yet recruiting
Armelle CATY
Armelle Caty, Principal Investigator

Hôpital Saint Vincent de Paul, Lille 59020, France; Not yet recruiting
Christophe DESAUW, Email: desauw.christophe@ghicl.net
Christophe DESAUW, Principal Investigator

Centre Leon Berard, Lyon 69373, France; Recruiting
Aude FLECHON, Principal Investigator

Institut Paoli Calmettes, Marseille 13273, France; Recruiting
Gwenaëlle GRAVIS-MESCAM, Dr, Email: gravisg@marseille.fnclcc.fr
Gwenaëlle GRAVIS-MESCAM, Principal Investigator

CHU Nimes, Nimes 30000, France; Recruiting
Mounira EL DEMERY, Phone: 04 66 68 43 77, Email: mounia.eldemery@chu-nimes.fr
Mounira EL DEMERY, Principal Investigator

Chr Orleans, Orleans 45100, France; Recruiting
Jérôme MEUNIER, Dr, Email: jerome.meunier@chr-orleans.fr
Jérôme Meunier, Principal Investigator

Institut Curie/Claudius Regaud, Paris 75005, France; Not yet recruiting
Philippe BEUZEBOC, Principal Investigator

Centre Hospitalier Lyon Sud, Pierre-benite, France; Recruiting
Claire FALANDRY, Principal Investigator

Centre Hospitalier de La Region D'Annecy, Pringy Cedex 74374, France; Recruiting
Laetitia STEFANI, Dr, Email: lstefani@ch-annecy.fr
Laetitia STEFANI, Principal Investigator

Polyclinique Francheville, Périgueux 24000, France; Recruiting
Laurent CANY, Phone: 05 53 02 13 32, Email: l.cany@oncoradio24.com
Laurent CANY, Principal Investigator

Institut Curie - Centre Rene Huguenin, Saint-cloud 92210, France; Not yet recruiting
Alain GOUPIL, Dr, Email: alain.goupil@curie.net
Alain GOUPIL, Principal Investigator

Ico - Centre Rene Gauducheau, Saint-herblain Cedex 44885, France; Recruiting
Emmanuelle BOMPAS, Dr, Email: e-bompas@nantes.fnclcc.fr
Emmanuelle BOMPAS, Principal Investigator

CH de Senlis, Senlis 60300, France; Recruiting
Elisabeth CAROLA, Email: elisabeth.carola@ch-senlis.fr
Elisabeth CAROLA, Principal Investigator

Centre Paul Strauss, Strasbourg 67065, France; Not yet recruiting
Christian BOREL, Dr, Email: cborel@strasbourg.fnclcc.fr
Christian Borel, Principal Investigator

Hôpitaux du Léman, Thonon-les-bains 74200, France; Not yet recruiting
Khoutir MAHOUR BACHA, Email: k-mahour@ch-hopitauxduleman.fr
Khoutir MAHOUR BACHA, Principal Investigator

Clinique Pasteur, Toulouse, France; Recruiting
Igor LATORZEFF, Principal Investigator

Clinique Saint Jean du Languedoc, Toulouse 31400, France; Not yet recruiting
Etienne SUC, Email: esucsjl@club-internet.fr
Etienne SUC, Principal Investigator

Institut Claudius Regaud, Toulouse 31052, France; Recruiting
Loïc MOUREY, Phone: 05 61 42 41 74, Email: loic.mourey@claudiusregaud.fr
Loic Mourey, Principal Investigator

Polyclinique Du Parc, Toulouse 31078, France; Recruiting
Igor LATORZEFF, Dr, Email: i.latorzeff@clinique-pasteur.com
Igor LATORZEFF, Principal Investigator

Additional Information

Starting date: November 2010
Last updated: January 29, 2013

Page last updated: August 23, 2015

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