Patients suffering from histologically or cytologically confirmed stage IV lung or breast cancer with progressive or recurrent brain metastases after prior external beam radiotherapy will receive treatment with cabazitaxel until progression of brain metastases (BM) or unacceptable toxicity.
Cabazitaxel is a new taxane compound that exhibited a broad spectrum of in vivo antitumor activity, not only in docetaxel - sensitive tumor models, but also in tumors models in which docetaxel was poorly or not active. In contrast to other taxanes, cabazitaxel has the ability to cross the blood-brain-barrier. Marked antitumor activity was obtained in nude mice bearing intracranial glioblastomas. Consequently, there is a good rationale to investigate cabazitaxel in patients with breast or lung cancer and recurrent or progressive brain metastases. The primary object of the study is to measure objective tumor response of brain metastases for patients with breast or lung cancer and recurrent or progressive brain metastases.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Cabazitaxel 25 mg/m2 i.v. infusion (infusion time about 1h) on D1 of each 21-day cycle. Continuation of treatment until progression of brain metastases or unacceptable toxicity.
Kliniken Nordoberpfalz, AG Klinikum Weiden, Medizinische Kliniken I
Weiden, Bavaria, Germany
Objective tumor response of brain metastases
Objective tumor response of brain metastases (Complete response (CR) or partial response (PR) or at least a minor response (MR; 25-50% reduction) according to WHO criteria1,2 and Iwamoto3 confirmed by magnetic resonance imaging (MRI))
Time frame: approx. 12 month
Overall Survival
Efficacy measure
Time frame: approx. 12 month
Progression free-survival for brain metastases
Efficacy measure
Time frame: approx. 12 month
progression-free survival for extracerebral tumor disease
Efficacy measure
Time frame: approx. 12 month
Time to treatment failure of brain metastases
Efficacy measure
Time frame: 12 month
Quality of life
Efficacy measure, assessed with EORTC QLQ-C30 and additional module BN20 questionnaire
Time frame: approx. 12 month
Type, incidence and severity of adverse events
Safety measure
Time frame: approx. 12 month
Dose reduction or discontinuation of study drug cabazitaxel due to adverse events
Safety measure
Time frame: approx. 12 month
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