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
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Lung Cancer
Recurrent Brain Metastases
Progressive Brain Metastases
Drug: Cabazitaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
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)

Resource links provided by NLM:


Further study details as provided by AIO-Studien-gGmbH:

Primary Outcome Measures:
  • 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))


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 63
Study Start Date: September 2014
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm
Patients receive Cabazitaxel 25 mg/m2 i.v. infusion. This trial is a single arm trial.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02166658

Contacts
Contact: Helge Schröder, Dipl.- Biol. +49 30 8145 344 ext 35 helge.schroeder@aio-studien-ggmbh.de

Locations
Germany
Kliniken Nordoberpfalz, AG Klinikum Weiden, Medizinische Kliniken I Not yet recruiting
Weiden, Bayern, Germany, 92637
Contact: Frank Kullmann, Prof. Dr.       frank.kullmann@kliniken-nordoberpfalz.ag   
Principal Investigator: Frank Kullmann, Prof. Dr.         
Sponsors and Collaborators
AIO-Studien-gGmbH
Sanofi
Investigators
Principal Investigator: Frank Kullmann, Prof. Dr. Kliniken Nordoberpfalz AG, Klinikum Weiden, Medizinische Kliniken I
  More Information

Additional Information:
No publications provided

Responsible Party: AIO-Studien-gGmbH
ClinicalTrials.gov Identifier: NCT02166658     History of Changes
Other Study ID Numbers: AIO-ZNS-0113, CABAZL06457, 2013-005545-37
Study First Received: June 16, 2014
Last Updated: June 17, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AIO-Studien-gGmbH:
Patients with breast or lung cancer and recurrent or progressive brain
metastases

Additional relevant MeSH terms:
Breast Neoplasms
Lung Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 14, 2014