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

NCT ID: NCT02441894

Last Updated: 2017-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-11-30

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.

Detailed Description

The total duration of study is 254 days as maximum with 14 days for screening, maximum of 21 days times 10 cycles for treatment, and 30 days for follow up.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cabazitaxel

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.

Group Type: EXPERIMENTAL

CABAZITAXEL XRP6258

Intervention Type: DRUG

Pharmaceutical form:solution Route of administration: intravenous

PEG-G-CSF

Intervention Type: DRUG

Pharmaceutical form:solution Route of administration: subcutaneous

Prednisolone

Intervention Type: DRUG

Pharmaceutical form:tablet Route of administration: oral

Dexchlorpheniramine or Diphenhydramine

Intervention Type: DRUG

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

Ranitidine

Intervention Type: DRUG

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

Metoclopramide, Granisetron, or Ondansetron

Intervention Type: DRUG

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

Dexamethasone

Intervention Type: DRUG

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

Interventions

CABAZITAXEL XRP6258

Pharmaceutical form:solution Route of administration: intravenous

Intervention Type: DRUG

PEG-G-CSF

Pharmaceutical form:solution Route of administration: subcutaneous

Intervention Type: DRUG

Prednisolone

Pharmaceutical form:tablet Route of administration: oral

Intervention Type: DRUG

Dexchlorpheniramine or Diphenhydramine

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

Intervention Type: DRUG

Ranitidine

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

Intervention Type: DRUG

Metoclopramide, Granisetron, or Ondansetron

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

Intervention Type: DRUG

Dexamethasone

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

Intervention Type: DRUG

Other Intervention Names

JEVTANA; G-LASTA

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).
• Known lesion at brain or leptomeninx.
• Known acquired immunodeficiency syndrome (AIDS-related illnesses) or known human immunodeficiency virus (HIV) disease requiring antiretroviral treatment.
• Active varicella zoster infection, anti-hepatitis C virus (HCV) antibody-positive (excluding patients negative for HCV virus in blood test or non-active seropositive patients with no hepatic abnormalities [AST, ALT, etc.]), or hepatitis B surface (HBs) antigen-positive.
• Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4 or 5 (wash-out period for a one week is necessary for patients who are already on these treatments or a two-week wash-out period is necessary for patients who are already on these treatments).
• Contraindication to be used corticosteroid.
• Patients with reproductive potential who do not agree to use an accepted and effective method of contraception during the study treatment period. The definition of "effective method of contraception" will be based on the Investigator's judgment.
• Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to registration.
• Prior history of severe hypersensitivity reaction (≥grade 3) or intolerance to prednisolone, PEG-G-CSF or G-CSF.
• Known hypersensitivity to the component of PEG-G-CSF and/or G-CSF.
• Myelogenous leukemia insufficient decrease of the number of blast in bone marrow, or found myeloblast in peripheral blood.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Minimum Eligible Age: 20 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 392004

Chuo-ku, Chiba, , Japan

Investigational Site Number 392008

Kita-gun, , Japan

Investigational Site Number 392007

Kobe-shi, Hyogo, , Japan

Investigational Site Number 392005

Nagakute-shi, Aichi, , Japan

Investigational Site Number 392006

Osaka Sayama-shi, Osaka, , Japan

Investigational Site Number 392001

Shinjuku-ku, Tokyo, , Japan

Investigational Site Number 392009

Yokohama, , Japan

Investigational Site Number 392002

Yokohama-shi, Kanagawa, , Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 31329922 (View on PubMed)

Other Identifiers

U1111-1155-8055

Identifier Type: -

Identifier Source: secondary_id

CABAZL07239

Identifier Type: -

Identifier Source: org_study_id