Second-line Chemotherapy in Castration Resistant Prostate Cancer

NCT01558219 | Completed Phase 2

• 1 other identifier: 2011-003156-39
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the safety of biweekly cabazitaxel for the treatment of metastatic castration resistant prostate cancer (mCRPC) patients previously treated with docetaxel containing regimen. The primary endpoint is safety. Secondary endpoints include time to treatment failure, response rate, overall survival and quality of life.

Conditions

Metastatic Prostate Cancer

Keywords

Metastatic prostate cancer

Outcome Measures

Primary Outcomes (1)

• Safety and tolerabilty

  NCI CTC-AE version 4 Adverse events in every organ systems and laborotory values (Grades from 0 to 5, 0=no adverse events, 5= dead)from baseline up to the end of the treatment

  every 2 weeks

Secondary Outcomes (1)

• Response rate

  PSA every 6 week, tumor assesment every 12 week

Study Arms (1)

acitive anticancer drug

EXPERIMENTAL

single cytostatic agent, cabazitaxel every second week in the treatment of castration resistant metastatic prostate cancer after docetaxel

Drug: cabacitaxel

Interventions

cabacitaxel DRUG

Jevtana® (cabazitaxel) 16 mg/m2 IV in 1 hour on day 1 given every second week

acitive anticancer drug

Eligibility Criteria

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

You may qualify if:

• Metastatic castration resistant prostate cancer
• Disease progression during or after docetaxel-containing regimen for mCRPC
• Surgical or medical castration
• WHO performance status \< 2
• Age \> 18 years
• Adequate bone marrow, liver and renal functions:
• Hematology:
• neutrophils \> 1.5 x 109/ l
• hemoglobin \> 100 g/l
• platelets \> 100 x 109/l
• Hepatic and renal functions:
• total bilirubin \<1 x ULN
• ALAT and ASAT \< 2.5 x ULN, alkaline phosphate \<6 x ULN.In the presence of extensive bone disease, alkaline phosphate \> 6 x ULN is accepted
• creatinine \< 1.5 x ULN (ie NCI CTC-AE grade \< 1)

You may not qualify if:

• Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment
• Prior therapy with radioisotopes
• Other malignant disease (except superficial non-melanoma skin cancer) within the past 5 years
• Serious liver disease
• History of severe hypersensitivity reaction (grade \> 3) to polysorbate 80 containing drugs
• Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who already are on these treatments)
• Other serious illness or medical condition:
• Serious cardiac disease; ischemic or thromboembolic cardiac disease, pulmonary emboli, cardiac infarction within 12 months
• Active infection
• Active peptic ulcer, uncontrolled diabetes mellitus or other contraindications for the use of corticosteroids
• Auto-immune disease (lupus, scleroderma, rheumatoid polyarthritis)
• Active grade \> 2 polyneuropathy

Sponsors & Collaborators

• Tampere University Hospital: lead
• Helsinki University Central Hospital: collaborator
• Turku University Hospital: collaborator
• Kuopio University Hospital: collaborator
• Seinajoki Central Hospital: collaborator

Study Sites (1)

Tampere University Hospital

Tampere, 33520, Finland

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Pirkko-Liisa I kellokumpu-Lehtinen, MD, PhD

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

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: November 25, 2011
• First Posted: March 20, 2012
• Study Start: November 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 21, 2016

Record last verified: 2016-10

Locations

FI (1)