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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


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Metastatic Prostate Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety and tolerabilty

Outcome 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

Outcome Time Frame:

every 2 weeks

Safety Issue:

Yes

Principal Investigator

Pirkko-Liisa I kellokumpu-Lehtinen, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tampere University Hospital

Authority:

Finland: Finnish Medicines Agency

Study ID:

2011-003156-39

NCT ID:

NCT01558219

Start Date:

November 2011

Completion Date:

December 2014

Related Keywords:

  • Metastatic Prostate Cancer
  • Metastatic prostate cancer
  • Prostatic Neoplasms

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