Second-line Chemotherapy in Castration Resistant Prostate Cancer (ProstyII)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Tampere University Hospital
Sponsor:
Collaborators:
Helsinki University Central Hospital
Turku University Hospital
Kuopio University Hospital
Seinajoki Central Hospital
Information provided by (Responsible Party):
Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT01558219
First received: November 25, 2011
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Metastatic Prostate Cancer
Drug: cabacitaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open, Single-arm, Multicenter, Phase II Trial Investigating the Safety of Biweekly Cabazitaxel in Metastatic Castration Resistant Prostate Cancer Patients Previously Treated With a Docetaxel-containing Regimen

Resource links provided by NLM:


Further study details as provided by Tampere University Hospital:

Primary Outcome Measures:
  • Safety and tolerabilty [ Time Frame: every 2 weeks ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Response rate [ Time Frame: PSA every 6 week, tumor assesment every 12 week ] [ Designated as safety issue: No ]
    Recist version 1.1 (response evaluation of solid solid tumors; Eisenhauer et al. JCO 2009;45:228-247)


Estimated Enrollment: 60
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: acitive anticancer drug
single cytostatic agent, cabazitaxel every second week in the treatment of castration resistant metastatic prostate cancer after docetaxel
Drug: cabacitaxel
Jevtana® (cabazitaxel) 16 mg/m2 IV in 1 hour on day 1 given every second week

Detailed Description:

The objective of this study is to explore new, biweekly schedule of cabazitaxel in metastatic castration resistant prostate cancer patients. A previous study has shown that the biweekly administration of docetaxel in 1st line setting of mCRPC is better tolerated than docetaxel administered every three weeks. Also, the efficacy of biweekly docetaxel was better than three-weekly docetaxel and biweekly dosing presented a significant overall survival benefit (ASCO 2011, Kellokumpu-Lehtinen et al. As the occurrence of neutropenia in the TROPIC trial was rather high, the hypothesis is to reduce the incidence of severe adverse events by administrating cabazitaxel more frequently, yet maintaining the same dose intensity as in every three weeks´ dosing schedule.

This study is designed to evaluate the safety of biweekly cabazitaxel for the treatment of 60 patients with metastatic castration resistant prostate cancer (mCRPC) patients previously treated with docetaxel containing regimen.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01558219

Contacts
Contact: Pirkko-Liisa I Kellokumpu-Lehtinen, MD,Phd +358331163227 pirkko-liisa.kellokumpu-lehtinen@pshp.fi

Locations
Finland
Tampere University Hospital Recruiting
Tampere, Finland, 33520
Principal Investigator: Pirkko-Liisa I Kellokumpu-Lehtinen, MD, PhD         
Sponsors and Collaborators
Tampere University Hospital
Helsinki University Central Hospital
Turku University Hospital
Kuopio University Hospital
Seinajoki Central Hospital
Investigators
Principal Investigator: Pirkko-Liisa I kellokumpu-Lehtinen, MD, PhD Tampere University Hospital
  More Information

No publications provided

Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01558219     History of Changes
Other Study ID Numbers: 2011-003156-39
Study First Received: November 25, 2011
Last Updated: February 5, 2014
Health Authority: Finland: Finnish Medicines Agency
Finland: Ethics Committee

Keywords provided by Tampere University Hospital:
Metastatic prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 26, 2014