Back to resultsSecond-line Chemotherapy in Castration Resistant Prostate Cancer (ProstyII)
Primary Purpose
Metastatic Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
Finland
Study Type
Interventional
Intervention
cabacitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Prostate Cancer focused on measuring Metastatic prostate cancer
Eligibility 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
Sites / Locations
- Tampere University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
acitive anticancer drug
Arm Description
single cytostatic agent, cabazitaxel every second week in the treatment of castration resistant metastatic prostate cancer after docetaxel
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Response rate
Recist version 1.1 (response evaluation of solid solid tumors; Eisenhauer et al. JCO 2009;45:228-247)
Full Information
NCT ID
NCT01558219
First Posted
November 25, 2011
Last Updated
October 20, 2016
Sponsor
Tampere University Hospital
Collaborators
Helsinki University Central Hospital, Turku University Hospital, Kuopio University Hospital, Seinajoki Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01558219
Brief Title
Second-line Chemotherapy in Castration Resistant Prostate Cancer
Acronym
ProstyII
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tampere University Hospital
Collaborators
Helsinki University Central Hospital, Turku University Hospital, Kuopio University Hospital, Seinajoki Central Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Prostate Cancer
Keywords
Metastatic prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
acitive anticancer drug
Arm Type
Experimental
Arm Description
single cytostatic agent, cabazitaxel every second week in the treatment of castration resistant metastatic prostate cancer after docetaxel
Intervention Type
Drug
Intervention Name(s)
cabacitaxel
Intervention Description
Jevtana® (cabazitaxel) 16 mg/m2 IV in 1 hour on day 1 given every second week
Primary Outcome Measure Information:
Title
Safety and tolerabilty
Description
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
Time Frame
every 2 weeks
Secondary Outcome Measure Information:
Title
Response rate
Description
Recist version 1.1 (response evaluation of solid solid tumors; Eisenhauer et al. JCO 2009;45:228-247)
Time Frame
PSA every 6 week, tumor assesment every 12 week
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pirkko-Liisa I kellokumpu-Lehtinen, MD, PhD
Organizational Affiliation
Tampere University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33520
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Second-line Chemotherapy in Castration Resistant Prostate Cancer
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