A Study of Cabazitaxel for Patients With Breast or Lung Cancer and Recurrent or Progressive Brain Metastases - Cabazitaxel for Brain Metastases (CaBaMet) (CaBaMet)
Recurrent Brain Metastases
Progressive Brain Metastases
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Cabazitaxel for Patients With Breast or Lung Cancer and Recurrent or Progressive Brain Metastases - Cabazitaxel for Brain Metastases (CaBaMet)|
- Objective tumor response of brain metastases [ Time Frame: approx. 12 month ]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))
- Overall Survival [ Time Frame: approx. 12 month ]Efficacy measure
- Progression free-survival for brain metastases [ Time Frame: approx. 12 month ]Efficacy measure
- progression-free survival for extracerebral tumor disease [ Time Frame: approx. 12 month ]Efficacy measure
- Time to treatment failure of brain metastases [ Time Frame: 12 month ]Efficacy measure
- Quality of life [ Time Frame: approx. 12 month ]Efficacy measure, assessed with EORTC QLQ-C30 and additional module BN20 questionnaire
- Type, incidence and severity of adverse events [ Time Frame: approx. 12 month ]Safety measure
- Dose reduction or discontinuation of study drug cabazitaxel due to adverse events [ Time Frame: approx. 12 month ]Safety measure
|Study Start Date:||August 2015|
|Estimated Study Completion Date:||September 2017|
|Estimated Primary Completion Date:||February 2017 (Final data collection date for primary outcome measure)|
Experimental: Single Arm
Patients receive Cabazitaxel 25 mg/m2 i.v. infusion. This trial is a single arm trial.
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.
Other Name: XRP6258, RPR116258A
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02166658
|Contact: Saskia Schulze||Saskia.Schulze@aio-studien-ggmbh.de|
|Kliniken Nordoberpfalz, AG Klinikum Weiden, Medizinische Kliniken I||Recruiting|
|Weiden, Bayern, Germany, 92637|
|Contact: Frank Kullmann, Prof. Dr. firstname.lastname@example.org|
|Principal Investigator: Frank Kullmann, Prof. Dr.|
|Principal Investigator:||Frank Kullmann, Prof. Dr.||Kliniken Nordoberpfalz AG, Klinikum Weiden, Medizinische Kliniken I|