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Prostate CancerPhase 2GERICO10NCT01254513

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

A Phase 2 study testing Docetaxel every 3 weeks + Prednisone and Docetaxel weekly+ Prednisone in people with Prostate Cancer, run by UNICANCER at 31 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 75 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Docetaxel every 3 weeks + Prednisone and Docetaxel weekly+ Prednisone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
31 sitesFrance
Study dates
9 Dec 2010to 27 Apr 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 years and older
  • Men only
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • "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)
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  • 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

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

France31 sites

  • Clinique Claude Bernard

    Albi, 81000

  • CHI Annemasse-Bonneville

    Ambilly, 74100

  • Centre Paul Papin

    Angers, 49933

  • CH de Blois

    Blois, 41016

  • Institut Bergonie

    Bordeaux, 33076

  • Centre Francois Baclesse

    Caen, 14076

  • CH Intercommunal

    Castres, 81108

  • Centre Hospitalier de Chambery

    Chambéry, 73011

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Clinique Sainte Marguerite

    Hyères, 83400

  • Chd Vendee

    La Roche-sur-Yon, 85925

  • Clinique Hartmann

    Levallois-Perret, 92300

  • Centre Oscar Lambret

    Lille, 59020

  • Hôpital Saint Vincent de Paul

    Lille, 59020

  • Centre Leon Berard

    Lyon, 69373

  • Institut Paoli Calmettes

    Marseille, 13273

  • CHU Nimes

    Nîmes, 30000

  • Chr Orleans

    Orléans, 45100

  • Institut Curie/Claudius Regaud

    Paris, 75005

  • Polyclinique Francheville

    Périgueux, 24000

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite

  • Centre Hospitalier de La Region D'Annecy

    Pringy, 74374

  • Institut Curie - Centre Rene Huguenin

    Saint-Cloud, 92210

  • Ico - Centre Rene Gauducheau

    Saint-Herblain, 44885

  • CH de Senlis

    Senlis, 60300

  • Centre Paul Strauss

    Strasbourg, 67065

  • Hôpitaux du Léman

    Thonon-les-Bains, 74200

  • Institut Claudius Regaud

    Toulouse, 31052

  • Polyclinique Du Parc

    Toulouse, 31078

  • Clinique Saint Jean du Languedoc

    Toulouse, 31400

  • Clinique Pasteur

    Toulouse

Other trials in France

About this study

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)

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.

Read the 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.

Conditions
Prostate Cancer
Being tested
Docetaxel every 3 weeks + Prednisone, Docetaxel weekly+ Prednisone
Keywords
Metastatic Prostate cancer, Elderly patients, Vulnerable and Frail (SIOG classification), castration-resistant
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Docetaxel every 3 weeks + PrednisoneDrug

    Also called TAXOTERE

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

  • Docetaxel weekly+ PrednisoneDrug

    Also called TAXOTERE

    • Docetaxel weekly 35 mg/m²/day at day 1 and day 8 of each cycle (J1 = J21)
    • Prednisone 10 mg/day continuously
Study groups in NCT01254513
Study groupRoleWhat they receive
Arm A - Docetaxel every 3 weeks + PrednisoneExperimental* Docetaxel: 60 mg/m²/day at C1 then 70 mg/m²/day for subsequent cycles every 3 weeks * Prednisone 10 mg/day continuously
Receives: Drug: Docetaxel every 3 weeks + Prednisone; Drug: Docetaxel weekly+ Prednisone
Arm B - Docetaxel weekly + PrednisoneExperimental* Docetaxel weekly 35 mg/m²/day on day 1 and day 8 of each cycle (J1 = J21) * Prednisone 10 mg/day continuously
Receives: Drug: Docetaxel weekly+ Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Up to 18 weeks (6 cycles of chemotherapy)

Secondary outcomes (6)

  1. Overall Survival

    Overall Survival is defined as the time from randomization until death for any cause or last follow-up news (censored data).

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

  2. Geriatric evaluation

    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)

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

  3. Number of patients with Adverse Events

    Tolerance and safety will be assessed through recording of adverse events using NCI-CTCAE toxicity classification V4.0.

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

  4. Quality of Life

    The impact of the chemotherapy is evaluated on the European Organisation for Research and Treatment of Cancer (EORTC) Quality Of Life - Questionnaire - QLQ-C30

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

  5. Vital signs measurement

    Tolerance and safety will be assessed through vital signs measurement.

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

  6. Prostate-specific antigen (PSA) measurements

    Efficacy will be assessed through monitoring PSA values

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2010 (estimated)
  2. Study start9 Dec 2010
  3. Primary completion10 May 2014
  4. Study completion27 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01254513
Sponsor's protocol ID
GERICO10/0910 (GetugP03)
Acronym
GERICO10
Status last verified
Jun 2021
First submitted
26 Oct 2010
Last updated
10 Jun 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel every 3 weeks + Prednisone and Docetaxel weekly+ Prednisone in people with Prostate Cancer, run by UNICANCER at 31 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of 2 different protocols of Docetaxel chemotherapy (time frame: Up to 18 weeks (6 cycles of chemotherapy)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01254513.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.

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