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

NCT01254513 | Completed Phase 2 DMC

• 1 other identifier: GERICO10/0910 (GetugP03)
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 31

Brief 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.

Conditions

Prostate Cancer

Keywords

Metastatic Prostate cancer; Elderly patients; Vulnerable and Frail (SIOG classification); castration-resistant

Outcome Measures

Primary Outcomes (1)

• Feasibility of 2 different protocols of Docetaxel chemotherapy

  Main criteria is the rate of patients receiving 6 cycles of treatment without experiencing any of the following criteria: * 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 ( ADL decrease \>= 2 points)

  Up to 18 weeks (6 cycles of chemotherapy)

Secondary Outcomes (6)

• Overall Survival

  From randomization until death for any cause or last follow-up news (censored data)

• Geriatric evaluation

  At baseline, D1 of Cycle 1 and Cycle 4, at the end of treatment and at follow-up visits

• Number of patients with Adverse Events

  At baseline, D1 of each cycle , at the end of treatment and at the follow-up visits

• Quality of Life

  At baseline, D1 of the Cycle 4, at the end of the treatment and at the follow-up visits

• Vital signs measurement

  At baseline, D1 of each cycle , at the end of treatment and at the follow-up visits

Study Arms (2)

Arm A - Docetaxel every 3 weeks + Prednisone

EXPERIMENTAL

* Docetaxel: 60 mg/m²/day at C1 then 70 mg/m²/day for subsequent cycles every 3 weeks * Prednisone 10 mg/day continuously

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

Arm B - Docetaxel weekly + Prednisone

EXPERIMENTAL

* Docetaxel weekly 35 mg/m²/day on day 1 and day 8 of each cycle (J1 = J21) * Prednisone 10 mg/day continuously

Drug: Docetaxel weekly+ Prednisone

Interventions

Docetaxel every 3 weeks + Prednisone DRUG

* Docetaxel IV 60 mg/m²/d then IV 70 mg/m²/d for subsequent cycles every 3 weeks * Prednisone 10 mg/day continuously

Also known as: TAXOTERE

Arm A - Docetaxel every 3 weeks + Prednisone

Docetaxel weekly+ Prednisone DRUG

* Docetaxel weekly 35 mg/m²/day at day 1 and day 8 of each cycle (J1 = J21) * Prednisone 10 mg/day continuously

Also known as: TAXOTERE

Arm A - Docetaxel every 3 weeks + Prednisone; Arm B - Docetaxel weekly + Prednisone

Eligibility Criteria

• Age: 75 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• "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

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (31)

Clinique Claude Bernard

Albi, 81000, France

Location

CHI Annemasse-Bonneville

Ambilly, 74100, France

Location

Centre Paul Papin

Angers, 49933, France

Location

CH de Blois

Blois, 41016, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Francois Baclesse

Caen, 14076, France

Location

CH Intercommunal

Castres, 81108, France

Location

Centre Hospitalier de Chambery

Chambéry, 73011, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Clinique Sainte Marguerite

Hyères, 83400, France

Location

Chd Vendee

La Roche-sur-Yon, 85925, France

Location

Clinique Hartmann

Levallois-Perret, 92300, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Hôpital Saint Vincent de Paul

Lille, 59020, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Institut Paoli Calmettes

Marseille, 13273, France

Location

CHU Nimes

Nîmes, 30000, France

Location

Chr Orleans

Orléans, 45100, France

Location

Institut Curie/Claudius Regaud

Paris, 75005, France

Location

Polyclinique Francheville

Périgueux, 24000, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Location

Centre Hospitalier de La Region D'Annecy

Pringy, 74374, France

Location

Institut Curie - Centre Rene Huguenin

Saint-Cloud, 92210, France

Location

Ico - Centre Rene Gauducheau

Saint-Herblain, 44885, France

Location

CH de Senlis

Senlis, 60300, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

Hôpitaux du Léman

Thonon-les-Bains, 74200, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Polyclinique Du Parc

Toulouse, 31078, France

Location

Clinique Saint Jean du Languedoc

Toulouse, 31400, France

Location

Clinique Pasteur

Toulouse, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Prednisone; Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Loic Mourey

  Institut Claudius Regaud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2010
• First Posted: December 6, 2010
• Study Start: December 9, 2010
• Primary Completion: May 10, 2014
• Study Completion: April 27, 2017
• Last Updated: June 10, 2021

Record last verified: 2021-06

Locations

FR (31)