Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Feasibility of a Chemotherapy With Docetaxel-Prednisone for Castration-resistant Metastatic Prostate Cancer Elderly Patients (GERICO10)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by UNICANCER.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
UNICANCER
ClinicalTrials.gov Identifier:
NCT01254513
First received: October 26, 2010
Last updated: January 29, 2013
Last verified: January 2013
  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.


Condition Intervention Phase
Prostate Cancer
Drug: Docetaxel every 3 weeks + Prednisone
Drug: Docetaxel weekly+ Prednisone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by UNICANCER:

Primary Outcome Measures:
  • Feasibility of 2 different protocols of Docetaxel chemotherapy [ Time Frame: Up to 18 weeks (6 cycles of chemotherapy) ] [ Designated as safety issue: Yes ]

    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)


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: From randomization until death for any cause or last follow-up news (censored data) ] [ Designated as safety issue: Yes ]
    Overall Survival is defined as the time from randomization until death for any cause or last follow-up news (censored data).

  • Geriatric evaluation [ Time Frame: At baseline, D1 of Cycle 1 and Cycle 4, at the end of treatment and at follow-up visits ] [ Designated as safety issue: No ]

    The impact of the chemotherapy will be evaluated on Comprehensive Geriatric Assessment :

    • Test de screening G8
    • Cumulative Illness Rating Scale(CIRSG)
    • Folstein Mini Mental State (MMS)
    • Activity of Daily Living (ADL)
    • Instrumental Activity of Daily Living (IADL)
    • Geriatric Depression Scale (GDS)
    • Mini Nutritionnal Assessment (MNA)

  • 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 ] [ Designated as safety issue: Yes ]
    Tolerance and safety will be assessed through recording of adverse events using NCI-CTCAE toxicity classification V4.0.

  • Quality of Life [ Time Frame: At baseline, D1 of the Cycle 4, at the end of the treatment and at the follow-up visits ] [ Designated as safety issue: No ]
    The impact of the chemotherapy is evaluated on the European Organisation for Research and Treatment of Cancer (EORTC) Quality Of Life - Questionnaire - QLQ-C30

  • Vital signs measurement [ Time Frame: At baseline, D1 of each cycle , at the end of treatment and at the follow-up visits ] [ Designated as safety issue: Yes ]
    Tolerance and safety will be assessed through vital signs measurement.

  • Prostate-specific antigen (PSA) measurements [ Time Frame: At baseline, D1 of each cycle , at the end of treatment and at the follow-up visits ] [ Designated as safety issue: No ]
    Efficacy will be assessed through monitoring PSA values


Estimated Enrollment: 144
Study Start Date: November 2010
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A - Docetaxel every 3 weeks + Prednisone
  • 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
  • Docetaxel IV 60 mg/m²/d then IV 70 mg/m²/d for subsequent cycles every 3 weeks
  • Prednisone 10 mg/day continuously
Other Name: TAXOTERE
Drug: Docetaxel weekly+ Prednisone
  • Docetaxel weekly 35 mg/m²/day at day 1 and day 8 of each cycle (J1 = J21)
  • Prednisone 10 mg/day continuously
Other Name: TAXOTERE
Experimental: Arm B - Docetaxel weekly + Prednisone
  • 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
  • Docetaxel weekly 35 mg/m²/day at day 1 and day 8 of each cycle (J1 = J21)
  • Prednisone 10 mg/day continuously
Other Name: TAXOTERE

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

Ages Eligible for Study:   75 Years and older   (Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01254513

Locations
France
Clinique Claude Bernard
Albi, France, 81000
CHI Annemasse-Bonneville
Ambilly, France, 74100
Centre Paul Papin
Angers, France, 49933
CH de Blois
Blois, France, 41016
Institut Bergonie
Bordeaux Cedex, France, 33076
Centre Francois Baclesse
Caen, France, 14076
CH Intercommunal
Castres, France, 81108
Centre Hospitalier de Chambery
Chambery, France, 73011
Centre Jean Perrin
Clermont-ferrand, France, 63011
Clinique Sainte Marguerite
Hyeres, France, 83400
Chd Vendee
La Roche Sur Yon, France, 85925
Clinique Hartmann
Levallois-perret, France, 92300
Centre Oscar Lambret
Lille, France, 59020
Hôpital Saint Vincent de Paul
Lille, France, 59020
Centre Leon Berard
Lyon, France, 69373
Institut Paoli Calmettes
Marseille, France, 13273
CHU Nimes
Nimes, France, 30000
Chr Orleans
Orleans, France, 45100
Institut Curie/Claudius Regaud
Paris, France, 75005
Centre Hospitalier Lyon Sud
Pierre-benite, France
Centre Hospitalier de La Region D'Annecy
Pringy Cedex, France, 74374
Polyclinique Francheville
Périgueux, France, 24000
Institut Curie - Centre Rene Huguenin
Saint-cloud, France, 92210
Ico - Centre Rene Gauducheau
Saint-herblain Cedex, France, 44885
CH de Senlis
Senlis, France, 60300
Centre Paul Strauss
Strasbourg, France, 67065
Hôpitaux du Léman
Thonon-les-bains, France, 74200
Institut Claudius Regaud
Toulouse, France, 31052
Polyclinique Du Parc
Toulouse, France, 31078
Clinique Saint Jean du Languedoc
Toulouse, France, 31400
Clinique Pasteur
Toulouse, France
Sponsors and Collaborators
UNICANCER
Investigators
Principal Investigator: Loic Mourey Institut Claudius Regaud
  More Information

Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT01254513     History of Changes
Other Study ID Numbers: GERICO10/0910 (GetugP03) 
Study First Received: October 26, 2010
Last Updated: January 29, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by UNICANCER:
Metastatic Prostate cancer
Elderly patients
Vulnerable and Frail (SIOG classification)
castration-resistant

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Prednisone
Docetaxel
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 02, 2016