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: +33.1.71.93.67.07, Email: c-orsini@unicancer.fr
Summary
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 SurvivalGeriatric 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.
Eligibility
Minimum age: 75 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
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,
chemotherapy)
- 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
adults
Locations and Contacts
Christine Orsini, Phone: +33.1.71.93.67.07, 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 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 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
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