Second-line Chemotherapy in Castration Resistant Prostate Cancer (ProstyII)
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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: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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 |
- 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
- 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)
| Estimated Enrollment: | 60 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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| Contact: Pirkko-Liisa I Kellokumpu-Lehtinen, MD,Phd | +358331163227 | pirkko-liisa.kellokumpu-lehtinen@pshp.fi |
| Finland | |
| Tampere University Hospital | Recruiting |
| Tampere, Finland, 33520 | |
| Principal Investigator: Pirkko-Liisa I Kellokumpu-Lehtinen, MD, PhD | |
| Principal Investigator: | Pirkko-Liisa I kellokumpu-Lehtinen, MD, PhD | Tampere University Hospital |
More Information
No publications provided
| Responsible Party: | Tampere University Hospital |
| ClinicalTrials.gov Identifier: | NCT01558219 History of Changes |
| Other Study ID Numbers: | 2011-003156-39 |
| Study First Received: | November 25, 2011 |
| Last Updated: | March 28, 2013 |
| Health Authority: | Finland: Finnish Medicines Agency Finland: Ethics Committee |
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 |
ClinicalTrials.gov processed this record on June 18, 2013