Combination of Cabazitaxel With Prednisolone With Primary Prophylaxis With PEG-G-CSF in Treatment of Patients With Prostate Cancer

NCT02441894 | Completed Phase 4

• 2 other identifiers: CABAZL07239U1111-1155-8055
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 8

Brief Summary

Primary Objective: To assess the tolerability of cabazitaxel 25 mg per body surface area (m\^2) with primary prophylactic polyethylene glycol-granulocyte-colony stimulating factor (PEG-G-CSF) in terms of the incidence rate of febrile neutropenia (FN) (defined: absolute neutrophil count \[ANC\] \<1000 per volume \[mm\^3\] and a single temperature of \>38.3 degree or a sustained temperature of ≥38 degree Celsius for more than one hour) during Cycle 1. Secondary Objective: To assess overall rate of FN and grade ≥3 neutropenia and diarrhea; frequencies of dose delay due to adverse events (AEs); dose reduction due to AEs; relative dose intensity; incidences of FN-related hospitalization and use of intravenous (IV) anti-infectives; tolerability according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0; prostate specific antigen (PSA) response (50% decrease); tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 if available.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Number of patients with FN (all grades) during study Cycle 1

  3 weeks (during study Cycle 1)

Secondary Outcomes (10)

• Number of patients with FN (all grades)

  Up to 7 months as treatment period

• Number of patients with Grade ≥3 neutropenia

  Up to 7 months as treatment period

• Number of patients with Grade ≥3 diarrhea

  Up to 7 months as treatment period

• Number of dose delays in the start of drug administration due to AEs

  Up to 7 months as treatment period

• Number of dose reductions due to AEs

  Up to 7 months as treatment period

Study Arms (1)

Cabazitaxel

EXPERIMENTAL

25 mg/m\^2 of cabazitaxel is given intravenously in combination with prednisolone 10 mg orally per day. PEG-G-CSF is administered subcutaneously 24 hours after the completion of cabazitaxel infusion once every 3 weeks. Antihistamine (dexchlorpheniramine or diphenhydramine), corticosteroids (dexamethasone), and H2 antagonist (ranitidine) premedications will be administered by IV infusion at least 30 minutes prior to each dose of cabazitaxel. A prophylactic antiemetic treatment (metoclopramide, granisetron, or ondansetron) should be given to the patients in all cycles.

Drug: CABAZITAXEL XRP6258; Drug: PEG-G-CSF; Drug: Prednisolone; Drug: Dexchlorpheniramine or Diphenhydramine; Drug: Ranitidine; Drug: Metoclopramide, Granisetron, or Ondansetron; Drug: Dexamethasone

Interventions

CABAZITAXEL XRP6258 DRUG

Pharmaceutical form:solution Route of administration: intravenous

Also known as: JEVTANA

Cabazitaxel

PEG-G-CSF DRUG

Pharmaceutical form:solution Route of administration: subcutaneous

Also known as: G-LASTA

Cabazitaxel

Prednisolone DRUG

Pharmaceutical form:tablet Route of administration: oral

Cabazitaxel

Dexchlorpheniramine or Diphenhydramine DRUG

Pharmaceutical form:tablet, powder, or solution Route of administration: oral, intravenous or intramuscular

Cabazitaxel

Ranitidine DRUG

Pharmaceutical form:tablet or solution Route of administration: oral, intravenous or intramuscular

Cabazitaxel

Metoclopramide, Granisetron, or Ondansetron DRUG

Pharmaceutical form:tablet, powder, jelly, or solution Route of administration: oral, intravenous or intramuscular

Cabazitaxel

Dexamethasone DRUG

Pharmaceutical form:tablet, capsule, or solution Route of administration: oral or intravenous

Cabazitaxel

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with chemotherapy including docetaxel.
• Male patients.
• Patients must have either measurable or nonmeasurable disease, or documented rising PSA levels.
• Patients signed informed consent.

You may not qualify if:

• Age \<20 at registration.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥2.
• Inadequate organ and bone marrow function at registration as evidenced by:
• Hemoglobin \<10.0 g/dL.
• ANC \<5 x 10\^9/L.
• Platelet count \<100 x 10\^9/L.
• Aspartate transaminase (AST) and/or alanine aminotransferase (ALT) \>1.5 x upper limit of normal (ULN).
• Total bilirubin \>1.0 x ULN.
• Serum creatinine \>1.5 x ULN. Serum creatinine is 1.0-1.5 x ULN and creatinine clearance is under 60 mL/min (calculated according to Chronic Kidney Disease Epidemiology Collaboration \[CKD-EP\]).
• Prior isotope therapy or radiotherapy to ≥30% of bone marrow. At the first study drug administration day, patient has not elapsed 8 weeks (12 weeks for strontium-89) from the day prior isotope therapy finished.
• Prior surgery, radiation, chemotherapy, or other anticancer therapy within 4 weeks prior to enrollment in the study.
• Symptomatic peripheral neuropathy grade ≥2 (NCI CTCAE v.4.0).
• History of severe hypersensitivity reaction (grade ≥3) to polysorbate 80 containing drugs.
• Prior and other concurrent malignancy, excepted cases are as follows; basal cell carcinoma or squamous cell carcinoma of skin, or superficial (pTis, pTa, and pT1) bladder cancer (including immunotherapy) treated adequately, any other cancer completed the chemotherapy more than 5 years ago and been more than 5 years as disease free duration.
• Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus).

Sponsors & Collaborators

• Sanofi: lead

Study Sites (8)

Investigational Site Number 392004

Chuo-ku, Chiba, Japan

Location

Investigational Site Number 392008

Kita-gun, Japan

Location

Investigational Site Number 392007

Kobe-shi, Hyogo, Japan

Location

Investigational Site Number 392005

Nagakute-shi, Aichi, Japan

Location

Investigational Site Number 392006

Osaka Sayama-shi, Osaka, Japan

Location

Investigational Site Number 392001

Shinjuku-ku, Tokyo, Japan

Location

Investigational Site Number 392009

Yokohama, Japan

Location

Investigational Site Number 392002

Yokohama-shi, Kanagawa, Japan

Location

Related Publications (1)

• Kosaka T, Uemura H, Sumitomo M, Harada K, Sugimoto M, Hayashi N, Yoshimura K, Fukasawa S, Ecstein-Fraisse E, Sunaga Y, Oya M. Impact of pegfilgrastim as primary prophylaxis for metastatic castration-resistant prostate cancer patients undergoing cabazitaxel treatment: an open-label study in Japan. Jpn J Clin Oncol. 2019 Aug 1;49(8):766-771. doi: 10.1093/jjco/hyz051.

  PMID: 31329922 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

cabazitaxel; pegylated granulocyte colony-stimulating factor, human; Prednisolone; dexchlorpheniramine; Diphenhydramine; Ranitidine; Metoclopramide; Granisetron; Ondansetron; Dexamethasone

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)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzamides; Amides; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Phenyl Ethers; Phenols; Azabicyclo Compounds; Aza Compounds; Indazoles; Pyrazoles; Azoles; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Imidazoles; Carbazoles; Indoles; Heterocyclic Compounds, 3-Ring; Steroids, Fluorinated

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2015
• First Posted: May 12, 2015
• Study Start: April 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 24, 2017

Record last verified: 2017-01

Locations

JP (8)