Study of the Effect of Chemotherapy With Cabazitaxel on Prostate Cancer

NCT02512458 | Completed Phase 2

• 2 other identifiers: HE 9A/142014-004485-21
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 6

Brief Summary

This is a prospective, open-label, single arm translational study of cabazitaxel in bone Castration Resistant metastatic Pancreatic Cancer (mCRPC) patients. Patient will be treated with intravenous (iv) cabazitaxel 25mg/m2 every (q) 21days per standard clinical practice for up to 10 cycles or until disease progression or unacceptable toxicity or physician's decision or patient's consent withdrawal (whichever occurs first).

Conditions

Bone Metastatic Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Molecular effects of treatment with Cabazitaxel on the tumor microenvironment

  To explore molecular effects of treatment with Cabazitaxel on the tumor microenvironment of patients with mCRPC in correlation with measures of outcome (ie clinical benefit, Prostate-Specific Androgen (PSA) decline, radiographic response, time to treatment discontinuation), in an effort to identify predictors of response or resistance to therapy.

  On week 9 and on week 36

Secondary Outcomes (10)

• Eastern Cooperative Oncology Group (ECOG) performance status

  Up to 30 weeks

• PSA response

  Up to 30 weeks

• Radiological progression-free survival according to Prostate Cancer Working Group 2 (PCWG2)

  Up to 30 weeks or until Disease Progression

• Pain status using a numerical rating scale from 0 to 10.

  Up to 30 weeks

• Time to best clinical benefit (based on pain, analgesic consumption, and performance status)

  Up to 30 weeks

Study Arms (1)

Cabazitaxel

EXPERIMENTAL

Patient will be treated with iv cabazitaxel 25mg/m2 q 21days per standard clinical practice for up to 10 cycles or until disease progression or unacceptable toxicity or physician's decision or patient's consent withdrawal (whichever occurs first).

Drug: Cabazitaxel

Interventions

Cabazitaxel DRUG

Also known as: Jevtana

Cabazitaxel

Eligibility Criteria

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

You may qualify if:

• Male patients older than 18 years
• Histologically proven adenocarcinoma of the prostate
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Serum testosterone levels \< 50ng/ml (1.7 nmol/L)
• Ongoing gonadal androgen deprivation therapy with Luteinizing Hormone-Releasing Hormone (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.

You may not qualify if:

• 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
• Ιnitiation 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

Sponsors & Collaborators

• Hellenic Cooperative Oncology Group: lead
• Sanofi: collaborator

Study Sites (6)

Athens Medical Center, Dept of Medical Oncology

Athens, Maroussi, 15125, Greece

Location

EUROMEDICA General Clinic of Thessaloniki

Thessaloniki, Thessaloniki, 54645, Greece

Location

General Hospital of Athens "Alexandra", Unit of Medical Oncology, Dept of Clinical Therapeutics

Athens, 11528, Greece

Location

Agii Anargiri Cancer Hospital, 3rd Dept of Medical Oncology

Athens, 14564, Greece

Location

Ioannina University Hospital, Dept of Medical Oncology

Ioannina, 45110, Greece

Location

Papageorgiou General Hospital, Dept of Medical Oncology

Thessaloniki, 56429, Greece

Location

MeSH Terms

Interventions

cabazitaxel

Study Officials

• Eleni Efstathiou, MD,Ass. Prof

  Unit of Medical Oncology,Department of Clinical Theraputics,General Hospital of Athens "Alexandra"

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: July 31, 2015
• Study Start: October 29, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 27, 2019
• Last Updated: February 10, 2020

Record last verified: 2020-02

Locations

GR (6)