Second-line Chemotherapy in Castration Resistant Prostate Cancer

Metastatic Prostate Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01558219
• Other study ID #: 2011-003156-39
• Status: Completed
• Phase: Phase 2
• First received: November 25, 2011
• Last updated: October 20, 2016
• Start date: November 2011
• Est. completion date: December 2014

Study information

• Verified date: October 2016
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines AgencyFinland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (5)

Lead Sponsor	Collaborator
Tampere University Hospital	Helsinki University Central Hospital, Kuopio University Hospital, Seinajoki Central Hospital, Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Response rate	Recist version 1.1 (response evaluation of solid solid tumors; Eisenhauer et al. JCO 2009;45:228-247)	PSA every 6 week, tumor assesment every 12 week	No