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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01558219
First Posted: March 20, 2012
Last Update Posted: October 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Helsinki University Central Hospital
Turku University Hospital
Kuopio University Hospital
Seinajoki Central Hospital
Information provided by (Responsible Party):
Tampere University Hospital
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]
    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 ]
    Recist version 1.1 (response evaluation of solid solid tumors; Eisenhauer et al. JCO 2009;45:228-247)


Enrollment: 60
Study Start Date: November 2011
Study Completion Date: December 2014
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01558219


Locations
Finland
Tampere University Hospital
Tampere, Finland, 33520
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

Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01558219     History of Changes
Other Study ID Numbers: 2011-003156-39
First Submitted: November 25, 2011
First Posted: March 20, 2012
Last Update Posted: October 21, 2016
Last Verified: October 2016

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