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 th

Condition: Prostate Cancer

Intervention:

• Drug: Docetaxel every 3 weeks + Prednisone
• Drug: Docetaxel weekly+ Prednisone

Purpose: 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01254513

Sponsor: UNICANCER

Primary Outcome Measures:

• Measure: Feasibility of 2 different protocols of Docetaxel chemotherapy
• Time Frame: Up to 18 weeks (6 cycles of chemotherapy)
• Safety Issue:

Secondary Outcome Measures:

• Measure: Overall Survival
• Time Frame: From randomization until death for any cause or last follow-up news (censored data)
• Safety Issue:
• Measure: Geriatric evaluation
• Time Frame: At baseline, D1 of Cycle 1 and Cycle 4, at the end of treatment and at follow-up visits
• Safety Issue:
• Measure: Number of patients with Adverse Events
• Time Frame: At baseline, D1 of each cycle , at the end of treatment and at the follow-up visits
• Safety Issue:
• Measure: Quality of Life
• Time Frame: At baseline, D1 of the Cycle 4, at the end of the treatment and at the follow-up visits
• Safety Issue:
• Measure: Vital signs measurement
• Time Frame: At baseline, D1 of each cycle , at the end of treatment and at the follow-up visits
• Safety Issue:
• Measure: Prostate-specific antigen (PSA) measurements
• Time Frame: At baseline, D1 of each cycle , at the end of treatment and at the follow-up visits
• Safety Issue:

Estimated Enrollment: 144

Study Start Date: November 2010

Phase: Phase 2

Eligibility:

• Age: minimum 75 Years maximum N/A
• Gender: 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, 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

Contact:

• Christine Orsini
• +33.1.71.93.67.07

Locations:

• Clinique Claude Bernard
• Albi 81000 France

• CHI Annemasse-Bonneville
• Ambilly 74100 France

• Centre Paul Papin
• Angers 49933 France

• CH de Blois
• Blois 41016 France

• Institut Bergonie
• Bordeaux Cedex 33076 France

• Centre Francois Baclesse
• Caen 14076 France

• CH Intercommunal
• Castres 81108 France

• Centre Hospitalier de Chambery
• Chambery 73011 France

• Centre Jean Perrin
• Clermont-ferrand 63011 France

• Clinique Sainte Marguerite
• Hyeres 83400 France

• Chd Vendee
• La Roche Sur Yon 85925 France

• Clinique Hartmann
• Levallois-perret 92300 France

• Centre Oscar Lambret
• Lille 59020 France

• Hôpital Saint Vincent de Paul
• Lille 59020 France

• Centre Leon Berard
• Lyon 69373 France

• Institut Paoli Calmettes
• Marseille 13273 France

• CHU Nimes
• Nimes 30000 France

• Chr Orleans
• Orleans 45100 France

• Institut Curie/Claudius Regaud
• Paris 75005 France

• Centre Hospitalier Lyon Sud
• Pierre-benite France

• Centre Hospitalier de La Region D’Annecy
• Pringy Cedex 74374 France

• Polyclinique Francheville
• Périgueux 24000 France

• Institut Curie – Centre Rene Huguenin
• Saint-cloud 92210 France

• Ico – Centre Rene Gauducheau
• Saint-herblain Cedex 44885 France

• CH de Senlis
• Senlis 60300 France

• Centre Paul Strauss
• Strasbourg 67065 France

• Hôpitaux du Léman
• Thonon-les-bains 74200 France

• Institut Claudius Regaud
• Toulouse 31052 France

• Polyclinique Du Parc
• Toulouse 31078 France

• Clinique Saint Jean du Languedoc
• Toulouse 31400 France

• Clinique Pasteur
• Toulouse France

View trial on ClinicalTrials.gov