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A Study of Cabazitaxel for Patients With Breast or Lung Cancer and Recurrent or Progressive Brain Metastases - Cabazitaxel for Brain Metastases (CaBaMet)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by AIO-Studien-gGmbH
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
AIO-Studien-gGmbH
ClinicalTrials.gov Identifier:
NCT02166658
First received: June 16, 2014
Last updated: June 17, 2014
Last verified: June 2014

June 16, 2014
June 17, 2014
September 2014
March 2016   (final data collection date for primary outcome measure)
Objective tumor response of brain metastases [ Time Frame: approx. 12 month ] [ Designated as safety issue: No ]
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))
Same as current
Complete list of historical versions of study NCT02166658 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: approx. 12 month ] [ Designated as safety issue: No ]
    Efficacy measure
  • Progression free-survival for brain metastases [ Time Frame: approx. 12 month ] [ Designated as safety issue: No ]
    Efficacy measure
  • progression-free survival for extracerebral tumor disease [ Time Frame: approx. 12 month ] [ Designated as safety issue: No ]
    Efficacy measure
  • Time to treatment failure of brain metastases [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Efficacy measure
  • Quality of life [ Time Frame: approx. 12 month ] [ Designated as safety issue: No ]
    Efficacy measure, assessed with EORTC QLQ-C30 and additional module BN20 questionnaire
  • Type, incidence and severity of adverse events [ Time Frame: approx. 12 month ] [ Designated as safety issue: Yes ]
    Safety measure
  • Dose reduction or discontinuation of study drug cabazitaxel due to adverse events [ Time Frame: approx. 12 month ] [ Designated as safety issue: Yes ]
    Safety measure
  • Quality of life [ Time Frame: approx. 12 month ] [ Designated as safety issue: No ]
    Efficacy measure, assessed with European Organisation for Research an Treatment of Cancer (EORTC) QLQ-C30 and additional module brain cancer (BN20) questionnaire
Same as current
Not Provided
Not Provided
 
A Study of Cabazitaxel for Patients With Breast or Lung Cancer and Recurrent or Progressive Brain Metastases - Cabazitaxel for Brain Metastases (CaBaMet)
A Phase II Study of Cabazitaxel for Patients With Breast or Lung Cancer and Recurrent or Progressive Brain Metastases - Cabazitaxel for Brain Metastases (CaBaMet)

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Breast Cancer
  • Lung Cancer
  • Recurrent Brain Metastases
  • Progressive Brain Metastases
Drug: Cabazitaxel
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
Experimental: Single Arm
Patients receive Cabazitaxel 25 mg/m2 i.v. infusion. This trial is a single arm trial.
Intervention: Drug: Cabazitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
63
October 2016
March 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients (≥ 18 years of age)
  • Histologically or cytologically confirmed stage IV lung or breast cancer with progressive or recurrent brain metastases
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Prior external beam radiotherapy (WBRT or SRS) of BM Patients suffering from small cell lung cancer (SCLC) who have been treated with chemotherapy and prophylactic cranial radiotherapy may be also enrolled.
  • At least one two-dimensional measurable lesion on brain MRI
  • Life expectancy at least 3 months
  • Females of childbearing potential (FCBP) must have a negative pregnancy test within 7 days of the first application of study treatment and must agree to use effective contraceptive birth control measures (Pearl Index < 1) during the course of the trial A female subject is considered to be of childbearing potential unless she is age ≥ 50 years and naturally amenorrhoeic for ≥ 2 year, or unless she is surgically sterile.
  • Males must agree to use effective contraception (Pearl Index < 1) during the course of the trial and for at least 6 months after last administration of study medication cabazitaxel. In addition males must agree to prevent contact with the ejaculate by another person throughout study treatment.

Exclusion Criteria:

Prior chemotherapy or targeted therapy (e.g. erlotinib, bevacizumab) for brain metastases

  • Any chemotherapy or targeted tumor therapy within two weeks of study inclusion or concomitantly
  • Any antihormonal tumor treatment within two weeks of study inclusion or concomitantly
  • Time interval to prior external beam radiotherapy less than 2 weeks
  • Suspected or known leptomeningeal disease
  • Peripheral neuropathy ≥ grade 2
  • Inadequate organ and bone marrow function as evidenced by:

Absolute neutrophil count (ANC) < 1.5 x 109/L; Hemoglobin < 10.0 g/dL; Platelet count < 100 x 109/L; Total bilirubin ≥ 1 x upper limit of normal (ULN); Aspartate aminotransferase (AST)/GOT and/or Alanine aminotransferase (ALT)/glutamate pyruvate transaminase (GPT) ≥ 1.5 x ULN; Serum creatinine > 1.5 x ULN. If creatinine 1.0 - 1.5 x ULN; creatinine clearance has to be calculated according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula and patients with creatinine clearance < 60 mL/min must be excluded

  • Other inadequate organ function according to investigator's discretion
  • History of hypersensitivity reaction to docetaxel
  • History of hypersensitivity reaction to polysorbate 80 containing drugs
  • Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
  • Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week washout period is necessary for patients who are already on these treatments; see also Section 10 and Appendix 3 and 4; dexamethasone is allowed)
  • Recently received or planned vaccination against yellow fever during study treatment
  • Pregnant or breast feeding females
  • Participation in any other clinical trial or treatment with any experimental drug within 28 day before enrolment to the study or during study participation until the end of treatment visit
  • Previous or concurrent tumor other than underlying tumor disease (breast or lung cancer) with the exception of cervical cancer in situ, adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder tumors (Ta,Tis, and T1) or any curatively treated tumors > 5 years prior to enrolment
Both
18 Years and older
No
Contact: Helge Schröder, Dipl.- Biol. +49 30 8145 344 ext 35 helge.schroeder@aio-studien-ggmbh.de
Germany
 
NCT02166658
AIO-ZNS-0113, CABAZL06457, 2013-005545-37
Yes
AIO-Studien-gGmbH
AIO-Studien-gGmbH
Sanofi
Principal Investigator: Frank Kullmann, Prof. Dr. Kliniken Nordoberpfalz AG, Klinikum Weiden, Medizinische Kliniken I
AIO-Studien-gGmbH
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP