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Trial Evaluating the Safety of 2 Schedules of Cabazitaxel in Elderly Men With mCRPC Previously Treated With a Docetaxel (CABASTY)

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ClinicalTrials.gov Identifier: NCT02961257
Recruitment Status : Recruiting
First Posted : November 10, 2016
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

Brief Summary:
The purpose of this study is to evaluate the incidence of grade ≥ 3 neutropenia and/or neutropenic complications (febrile neutropenia, neutropenic infection) with two schedules of cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in elderly men (≥ 65 years) with mCRPC previously treated with a docetaxel-containing regimen.

Condition or disease Intervention/treatment Phase
Prostate Cancer Metastatic Drug: cabazitaxel Drug: Prednisone Drug: Granulocyte colony-stimulating factor (G-CSF) Phase 3

Detailed Description:

Randomized, open-label, phase 3 trial in mCRPC patients aged ≥ 65 years.

Treatment:

  • Arm A : cabazitaxel 25 mg/m² on Day 1 of a 3-week cycle plus daily prednisone or
  • Arm B: cabazitaxel 16 mg/m² on Day 1 and Day 15 of a 4-week cycle plus daily prednisone.
  • Treatment will be continued for a maximum of 10 cycles unless there is documented disease progression or unacceptable toxicity.
  • Standard cabazitaxel premedication will be used
  • Prophylactic G-CSF (GRANOCYTE) will be injected from Day 3 to Day 7 after every administration cycle of cabazitaxel· All new hormonal treatment, including ODM-201, prior to study entry is allowed.
  • Patients who received Radium-223 are eligible for this study
  • Treatment with LHRH should not be discontinued.

Exploratory assessments:

CT-Scan (abdominal/pelvic/chest) or whole body MRI and Bone scan: at screening, every 3 months and EOT.

FACT-P questionnaire:at C1D1,each subsequent visit and EOT

Number of subjects:

Total:170 (85 per arm)

Statistical analysis:

A sample size of 77 evaluable patients per arm will achieve 80% power to detect a 20% difference in G3 neutropenia incidence between the 2 arms. The incidence in group cabazitaxel 25 mg/m2 q3w is assumed to be 32% and 12% on bi-weekly cabazitaxel arm. The test used is a two-sided Fisher's exact test at 0.05 significance level. Assuming 10% non-evaluable patients, 85 patients should be included in each arm for a total of 170. Patients will be stratified according to G8 score(< 14 vs. ≥ 14), and age (< 70 vs. ≥ 70) before randomization.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Multicenter, Phase III Trial Evaluating the Safety of 2 Schedules of Cabazitaxel (Bi-weekly Versus Tri-weekly) Plus Prednisone in Elderly Men (≥ 65years) With mCRPC Previously Treated With a Docetaxel-containing Regimen
Actual Study Start Date : May 5, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arm Intervention/treatment
Experimental: Arm A

Cabazitaxel 25 mg/m² intravenously over 1 hour on Day 1of a 3-week cycle, plus prednisone (or prednisolone) 10 mg orally given daily for a maximum of 10 cycles (ie 30 weeks of treatment).

Prophylactic Granulocyte colony-stimulating factor G-CSF (Granocyte) will be injected from Day 3 to Day 7 after every administration of cabazitaxel.

Drug: cabazitaxel
  • Arm A : cabazitaxel 25 mg/m² on Day 1 of a 3-week cycle plus daily prednisone or
  • Arm B: cabazitaxel 16 mg/m² on Day 1 and Day 15 of a 4-week cycle plus daily prednisone.
  • Treatment will be continued for a maximum of 10 cycles unless there is documented disease progression or unacceptable toxicity.
  • Standard cabazitaxel premedication will be used
Other Names:
  • Jevtana
  • XRP6258

Drug: Prednisone
Arm A:plus prednisone 10 mg orally given daily for a maximum of 10 cycles Arm B: plus prednisone 10 mg orally given per day up to 10 cycles

Drug: Granulocyte colony-stimulating factor (G-CSF)
Primary prophylaxis with Granulocyte Colony-Stimulating Factor (G-CSF) will be injected from Day 3 to Day 7 after every administration of cabazitaxel
Other Name: Granocyte

Experimental: Arm B
Cabazitaxel 16 mg/m2 on Day 1 and Day 15 of a 4-week cycle plus prednisone (or prednisolone) 10 mg per day up to 10 cycles (ie 40 weeks of treatment). Prophylactic Granulocyte colony-stimulating factor G-CSF (Granocyte) will be injected from Day 3 to Day 7 after every administration of cabazitaxel.
Drug: cabazitaxel
  • Arm A : cabazitaxel 25 mg/m² on Day 1 of a 3-week cycle plus daily prednisone or
  • Arm B: cabazitaxel 16 mg/m² on Day 1 and Day 15 of a 4-week cycle plus daily prednisone.
  • Treatment will be continued for a maximum of 10 cycles unless there is documented disease progression or unacceptable toxicity.
  • Standard cabazitaxel premedication will be used
Other Names:
  • Jevtana
  • XRP6258

Drug: Prednisone
Arm A:plus prednisone 10 mg orally given daily for a maximum of 10 cycles Arm B: plus prednisone 10 mg orally given per day up to 10 cycles

Drug: Granulocyte colony-stimulating factor (G-CSF)
Primary prophylaxis with Granulocyte Colony-Stimulating Factor (G-CSF) will be injected from Day 3 to Day 7 after every administration of cabazitaxel
Other Name: Granocyte




Primary Outcome Measures :
  1. Number of grade ≥ 3 neutropenia and/or neutropenic complications [ Time Frame: Up to 11 months ]

    To evaluate the incidence of grade ≥ 3 neutropenia (measured at Day 7 and Day 14) and/or neutropenic complications (febrile neutropenia, neutropenic infection) with two schedules of cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in elderly men (≥ 65 years) with mCRPC previously treated with a docetaxel-containing regimen.

    with two schedules of -+cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in elderly men with mCRPC previously treated with a docetaxel-containing regimen



Secondary Outcome Measures :
  1. Dose reductions [ Time Frame: through study completion, an average of 40 weeks ]
    Up to 11 months

  2. Radiological progression-free survival (rPFS) [ Time Frame: Up to 11 months ]
    CT-Scan (abdominal/pelvic/chest) or whole body MRI and Bone scan

  3. Time to PSA progression [ Time Frame: Up to 11 months ]
    Assessed at C1D1, at every each subsequent visit and EOT

  4. Time to first symptomatic Skeletal-Related Event (SRE) and incidence of SREs [ Time Frame: Up to 11 months ]
    Assessed at C1D1, at every each subsequent visit and EOT

  5. Time to opioid treatment (if relevant) [ Time Frame: Up to 11 months ]
  6. Prostate-specific antigen (PSA) response rate [ Time Frame: Up to 11 months ]
    Assessed at C1D1, at every each subsequent visit and EOT

  7. Quality of Life (FACT-P) [ Time Frame: Up to 11 months ]
    Assessed at C1D1, at every each subsequent visit and EOT

  8. Objective response rate (ORR) in measurable lesions (RECIST criteria 1.1 - only on metastasis [ Time Frame: Up to 11 months ]
    CT-Scan (abdominal/pelvic/chest) or whole body MRI

  9. Overall Survival (OS) [ Time Frame: up to 11 months ]
  10. Factors influencing survival [ Time Frame: Up to 11 months ]
    Factors influencing survival (duration of response to first ADT, serum testosterone, cumulative dose of cabazitaxel, neutrophils/lymphocytes ratio, Gleason score, G8, grade ≥3 neutropenia)

  11. Time to onset of grade ≥3 neutropenia [ Time Frame: Up to 11 months ]
    Hematology every week until EOT

  12. Grade ≥3 neutropenia duration ( from date of onset of grade ≥ 3 until grade ≤ 2) [ Time Frame: Up to 11 months ]
    Hematology every week until EOT

  13. Time to onset of grade ≥3 neutropenia by cycle [ Time Frame: Up to 11 months ]
    Analysis of grade ≥3 neutropenia and/or neutropenia by cycle

  14. Adverse events [ Time Frame: Up to 11 months ]
  15. Dose delay [ Time Frame: Up to 11 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient aged ≥ 65 years with mCRPC previously treated with docetaxel
  2. Medical or surgical castration with castrate level of testosterone (< 50 ng/dl) based on the EAU definition of castrate level of testosterone
  3. Progressive disease according to PCWG2
  4. Histologically proven prostate carcinoma
  5. Health status allowing use of chemotherapy: G8 > 14; or G8 score ≤ 14 with geriatric assessment concluding to reversible impairment allowing use of chemotherapy
  6. ECOG-PS 0, 1 or 2(ECOG-PS 2 should be related to prostate cancer)
  7. Adequate hematologic, liver and renal functions:

    1. Neutrophil count ≥1.5 109/L
    2. Haemoglobin ≥10 g/ dL
    3. Platelet count ≥100.109/L
    4. Total bilirubin ≤ 1 the upper limit of normal (ULN)
    5. Transaminases ≤ 1.5 ULN
    6. Serum creatinine ≤ 2.0 ULN
  8. Ongoing LHRH therapy at study entry
  9. Signed informed consent

Exclusion Criteria:

  1. History of severe hypersensitivity reaction (≥grade 3) to docetaxel
  2. History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs
  3. Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
  4. Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) (see Appendix E)
  5. PS >2 not related to prostate cancer disease
  6. G8 ≤ 14 with geriatric assessment contra-indicating standard cabazitaxel regimen
  7. Concomitant vaccination with yellow fever vaccine
  8. Patient who cannot be regularly followed or cannot answer to quality of life questionnaires because of psychological, social, familial or geographic reasons
  9. Participation in another clinical trial with any investigational drug within 30 days prior to study enrolment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02961257


Contacts
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Contact: Réza ELAIDI, PhD 00 33 (1)56 09 23 40 reza-thierry.elaidi-ext@aphp.fr
Contact: Houda BELHOUARI, MD houda.belhouari-ext@aphp.fr

Locations
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France
Hôpital Jean Minjoz Recruiting
Besançon, France, 25030
Contact: Antoine THIERY-VUILLEMIN, MD       a.thieryvuillemin@mac.com   
Hôpital Saint André, CHU de Bordeaux Recruiting
Bordeaux, France, 33075
Contact: Amandine QUIVY, MD       amandine.quivy@chu-bordeaux.fr   
Clinique Pasteur-CFRO Active, not recruiting
Brest, France, 29229
Centre Maurice Tubiana Active, not recruiting
Caen, France, 14000
Polyclinique Saint-Côme Not yet recruiting
Compiègne, France, 60204
Contact: Kais ALDABBAGH, MD       Kais.aldabbagh@stcome.com   
CHU Henri-Mondor Recruiting
Créteil, France, 94000
Contact       carolina.saldana@aphp.fr   
Principal Investigator: Carolina SALDANA, MD         
Centre Oscar Lambret Lille Not yet recruiting
Lille, France, 59000
Contact       T-Ryckewaert@o-lambret.fr   
Principal Investigator: Thomas RYCKEWAERT, MD         
Hôpital Belle-Isle Not yet recruiting
Metz, France, 57045
Contact: Jérôme PLAZA, MD       jerome.plaza@hp-metz.fr   
GHIRM Not yet recruiting
Montfermeil, France, 93370
Contact: Ida PAVESE         
Contact       ipavese@ch-montfermeil.fr   
Principal Investigator: Ida PAVESE, MD         
Institut de Cancérologie du Gard - CHU Recruiting
Nîmes, France, 30029
Contact       nadine.HOUEDE@chu-nimes.fr   
Principal Investigator: Nadine HOUEDE, MD         
Institut Mutualiste Montsouris Recruiting
Paris, France, 75014
Contact: Mostefa BENNAMOUN, MD       Mostefa.Bennamoun@imm.fr   
Hôpital Européen Georges Pompidou Recruiting
Paris, France, 75015
Contact: Stéphane OUDARD, MD    00 33 (1) 56 09 34 76    stephane.oudard@egp.aphp.fr   
Hôpital Universitaire Tenon Not yet recruiting
Paris, France, 75020
Contact: Ahmed KHALIL, MD       ahmed.khalil@aphp.fr   
Hôpital Cochin Recruiting
Paris, France, 75679
Contact: Jérôme ALEXANDRE, MD       jerome.alexandre@cch.aphp.fr   
CHU de Poitiers Not yet recruiting
Poitiers, France, 86021
Contact: Jean-Marc TOURANI, MD       Jean-Marc.TOURANI@chu-poitiers.fr   
CHU de Rouen Not yet recruiting
Rouen, France, 76000
Contact: Frédéric DI FIORE, MD       Frederic.DiFiore@chu-rouen.fr   
Clinique Armoricaine de Radiologie Recruiting
Saint-brieuc, France, 22015
Contact: Anne-Claire HARDY-BESSARD, MD       ac.hardy@cario-sante.fr   
HIA Bégin 69 avenue de Paris Recruiting
Saint-Mandé, France, 94160
Contact: Carole HELISSEY, MD       carole.helissey@gmail.com   
Centre Hospitalier de Sens Not yet recruiting
Sens, France, 89100
Contact: Laure CHAUVENET, MD       LCHAUVENET@ch-sens.fr   
Hôpitaux universitaires de Strasbourg Recruiting
Strasbourg, France, 67000
Contact       philippe.barthelemy@chru-strasbourg.fr   
Principal Investigator: Philippe BARTHELEMY, MD         
Hôpital FOCH Recruiting
Suresnes, France, 92151
Contact       p.beuzeboc@hopital-foch.com   
Principal Investigator: Philippe BEUZEBOC, MD         
Centre de cancérologie Les Dentellières Active, not recruiting
Valenciennes, France, 59300
Sponsors and Collaborators
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
Investigators
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Principal Investigator: Stephane OUDARD, MD, Ph.D Hôpital Européen Georges Pompidou, Oncology Department

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Responsible Party: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
ClinicalTrials.gov Identifier: NCT02961257     History of Changes
Other Study ID Numbers: CABASTY
First Posted: November 10, 2016    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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