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

November 25, 2011
February 5, 2014
November 2011
December 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01558219 on ClinicalTrials.gov Archive Site
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)
Same as current
Not Provided
Not Provided
 
Second-line Chemotherapy in Castration Resistant Prostate Cancer
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

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Prostate Cancer
Drug: cabacitaxel
Jevtana® (cabazitaxel) 16 mg/m2 IV in 1 hour on day 1 given every second week
Experimental: acitive anticancer drug
single cytostatic agent, cabazitaxel every second week in the treatment of castration resistant metastatic prostate cancer after docetaxel
Intervention: Drug: cabacitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact: Pirkko-Liisa I Kellokumpu-Lehtinen, MD,Phd +358331163227 pirkko-liisa.kellokumpu-lehtinen@pshp.fi
Finland
 
NCT01558219
2011-003156-39
No
Tampere University Hospital
Tampere University Hospital
  • Helsinki University Central Hospital
  • Turku University Hospital
  • Kuopio University Hospital
  • Seinajoki Central Hospital
Principal Investigator: Pirkko-Liisa I kellokumpu-Lehtinen, MD, PhD Tampere University Hospital
Tampere University Hospital
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP