Study of the effect of chemotherapy with cabazitaxel on prostate cancer

Phase 1

• Conditions: Castration resistant bone metastatic prostate cancer; MedDRA version: 18.0 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-004485-21-GR
• Lead Sponsor: Hellenic Cooperative Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-12
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

• Male patients older than 18 years
• Histologically proven adenocarcinoma of the prostate
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Serum testosterone levels < 50ng/ml (1.7 nmol/L)
• Ongoing gonadal androgen deprivation therapy with LHRH analogues or orchiectomy. Patients, who have not had an orchiectomy, must be maintained on effective LHRH analogue therapy for the duration of the trial
• Progression of disease despite androgen ablation - Either documented osseous or soft tissue metastatic disease progression or by PSA criteria progression
• Presence of bone metastases
• Off diethylstilbestrol (DES) or steroids treatment for = 4 weeks and for antiandrogens > 4 weeks.
• No prior treatment with cabazitaxel
• Able to comply with study requirements
• Written information delivered to the patient. Patient must be willing and able to comply with protocol requirements. All patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must also have signed an authorization for the release of their protected health information.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

• Histologic variants in the primary tumor (histologic variants other than adenocarcinoma)
• Concurrent therapy with other therapeutic or hormonal agent, including androgen receptor antagonists (bicalutamide, flutamide, nilutamide, enzalutamide), any dose of megestrol acetate (Megace), ketoconazole, abiraterone acetate, finasteride (Proscar), dutasteride (Avodart) any herbal product known to decrease PSA levels (e.g., Saw Palmetto and PC-SPES),
• Active infection or intercurrent illnesses that are not controlled
• Prior radiation therapy completed < 4 weeks prior to enrolment
• Planned palliative procedures for alleviation of bone pain such as radiation therapy or surgery
• Structurally unstable bone lesions suggesting impending fracture
• Any currently active” second malignancy, other than non-melanoma skin cancer. Patients are not considered to have a currently active” malignancy, if they have completed therapy and are considered by their physician to be at least less than 30% risk of relapse over next 3 months
• Active psychiatric illnesses/social situations that would limit compliance with protocol requirements.
• Active or uncontrolled autoimmune disease that may require corticosteroid therapy during study.
• Severely compromised immunological state, including being positive for the human immunodeficiency virus (HIV)
• Known acute or chronic hepatitis B or C
• Other investigational therapies (targeted or vaccine) will require a 4 week washout period before treatment initiation
• ?nitiation of bisphosphonate or denosumab therapy within 4 weeks prior to first dose of study drug. Patients on stable doses of bisphosphonates or denosumab that show subsequent tumor progression may continue on this medication; however, patients are discouraged to initiate bisphosphonate therapy during the study.
• Patients receiving an investigational drug within 4 weeks prior to enrolment
• History of severe hypersensitivity reaction (grade =3) to polysorbate 80 containing drugs
• Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
• 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)
• Inadequate organ or bone marrow function

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified