A Study of Cabazitaxel for Patients With Breast or Lung Cancer and Recurrent or Progressive Brain Metastases - Cabazitaxel for Brain Metastases (CaBaMet) (CaBaMet)
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|ClinicalTrials.gov Identifier: NCT02166658|
Recruitment Status : Terminated (After a recruitment of more than 2 years, only 8 patients have been registered.)
First Posted : June 18, 2014
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Lung Cancer Recurrent Brain Metastases Progressive Brain Metastases||Drug: Cabazitaxel||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||August 2015|
|Primary Completion Date :||April 2017|
|Study Completion Date :||January 18, 2018|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02166658
|Kliniken Nordoberpfalz, AG Klinikum Weiden, Medizinische Kliniken I|
|Weiden, Bayern, Germany, 92637|
|Principal Investigator:||Frank Kullmann, Prof. Dr.||Kliniken Nordoberpfalz AG, Klinikum Weiden, Medizinische Kliniken I|