Second-line Chemotherapy in Castration Resistant Prostate Cancer

Phase 2

Completed

• Conditions: Metastatic Prostate Cancer
• Interventions: Drug: cabacitaxel

• Registration Number: NCT01558219
• Lead Sponsor: Tampere University Hospital

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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-25
• Study First Submitted QC: 2012-03-19
• Study First Posted: 2012-03-20
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-20
• Last Update Posted: 2016-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
acitive anticancer drug	cabacitaxel	single cytostatic agent, cabazitaxel every second week in the treatment of castration resistant metastatic prostate cancer after docetaxel

Primary Outcome Measures

Name	Time	Method
Safety and tolerabilty	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

Name	Time	Method
Response rate	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)

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland