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Evaluation of Cabazitaxel in Patients With Brain Metastasis Secondary to Breast Cancer and NSCLC (CRANIAL)

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ClinicalTrials.gov Identifier: NCT01913067
Recruitment Status : Withdrawn (Scientific rationale is deemed obsolete. Funders lost interest in the trial.)
First Posted : July 31, 2013
Last Update Posted : July 24, 2014
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Jules Bordet Institute

Brief Summary:

A phase II trial evaluating Cabazitaxel in patients with brain metastasis secondary to breast and non-small-cell lung cancer (NSCLC).

OBJECTIVES:

Primary:

The purpose of this study is to determine if cabazitaxel can induce a reduction in the size brain metastasis in metastatic HER2-negative breast cancer and NSCLC with brain metastasis who were not previously treated with whole brain irradiation or require immediate brain irradiation.

Secondary:

  • To determine the effect of cabazitaxel on the time to initiating whole brain irradiation or radiosurgery
  • To determine the effect of cabazitaxel on the time to developing neurological symptoms
  • To determine the effect of cabazitaxel on the time to disease progression in the brain
  • To determine the effect of cabazitaxel on the time to disease progression outside the brain. This will be evaluated separately for the breast and NSCLC cohorts To determine the objective extra-cranial response (if applicable). This will be evaluated separately in the breast and NSCLC cohorts
  • To determine the safety of cabazitaxel

Condition or disease Intervention/treatment Phase
Brain Metastasis Breast Cancer Non Small Cell Lung Cancer Drug: Cabazitaxel Procedure: Contrast-enhanced whole brain MRI Phase 2

Detailed Description:
This is a single arm, prospective trial using a 2-stage Simon design, in which eligible patients will receive intravenous cabazitaxel for two cycles followed by response evaluation. Based on the pre-specified criteria of response (intra-cranial, patient will be allowed to continue on study drug.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Evaluating Cabazitaxel in Patients With Brain Metastasis Secondary to Breast and Non-small Cell Lung Cancer
Study Start Date : September 2013
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Cabazitaxel

Arm Intervention/treatment
Experimental: Cabazitaxel
Eligible patients will receive intravenous 25mg/m2 cabazitaxel every 3 weeks. Contrast-enhanced whole brain MRI will be performed every two cycles. Patients who show ≥50% volumetric reduction in the size of the brain lesion(s) will continue on cabazitaxel until disease progression or unacceptable toxicity. Patients who show evidence of disease progression and/or developed progressive neurological symptoms will be taken off study and offered whole brain irradiation. Patients who do not meet both criteria can have the choice either to continue on study drug or to be taken off study according to the investigator discretion.
Drug: Cabazitaxel
Intravenous, 25 mg/m2 every 3 weeks
Other Name: Jevtana

Procedure: Contrast-enhanced whole brain MRI
Evaluation of the volumetric reduction in the size of the brain lesion(s).




Primary Outcome Measures :
  1. Reduction of brain lesions. [ Time Frame: week 6 ]
    Objective response defined as a >= 50% volumetric reduction of brain lesions in the absence of increasing steroid use and progressive neurologic symptoms.


Secondary Outcome Measures :
  1. Time to whole brain irradiation or radiosurgery [ Time Frame: every 6 weeks until disease progression. ]
    Determine the effect of cabazitaxel on the time to initiating whole brain irradiation or radiosurgery

  2. Time to developing neurological symptoms. [ Time Frame: every 6 weeks until disease progression. ]
    Determine the effect of cabazitaxel on the time to developing neurological symptoms

  3. Time to progression in the brain [ Time Frame: every 6 weeks until disease progression. ]
    Determine the effect of cabazitaxel on the time to disease progression in the brain.

  4. Time to progression extra-cranial [ Time Frame: every 6 weeks until disease progression. ]
    Determine the effect of cabazitaxel on the time to disease progression outside the brain

  5. Toxicity [ Time Frame: every 3 weeks until 30 days after last treatment administration. ]
    Determine the safety of cabazitaxel



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Age>18, ECOG 0-1
  • Histologically confirmed 1) HER2-negative invasive breast carcinoma or 2) NSCLC
  • In patients with breast cancer, HER2-negative status by FISH or immunohistochemistry (score 0, or +1).
  • In patients with breast cancer, known estrogen and progesterone receptor status.
  • Evidence of measurable disease in the brain (at least 1cm)
  • Stable or decreasing dosage of steroids for 7 days prior to baseline MRI.
  • No evidence of (cortical) cognitive impairment as defined by a Mini-Mental Status Exam (MMSE) score ≥ 25/30.
  • No more than 4 prior lines of systemic chemotherapy in the metastatic setting
  • Adequate hematopoietic function defined as:

    • Hemoglobin ≥ 9.0g/dL
    • Absolute neutrophilic count ≥ 1.5 x 109L
    • Platelet count ≥ 100 x 109L
  • Adequate hepatic function defined as:

    • AST ≤ 2.5 x upper limit of normal (ULN)
    • ALT ≤ 2.5 x ULN
    • Total bilirubin ≤ 1.0 x ULN
  • Adequate renal function defined as serum creatinine ≤ 1.5 x ULN. If creatinine ranges from 1.0 - 1.5 x ULN, creatinine clearance determined by CKD-EPI formula should be calculated and only patients with clearance >60 mL/min are eligible
  • Adequate contraceptive method in patients with child-bearing potential.

Exclusion Criteria:

  • History of prior whole brain irradiation
  • Progressive neurological symptoms requiring immediate brain irradiation
  • Pregnancy or lactation
  • History of hypersensitivity reaction to taxanes
  • History of hypersensitivity to polysorbate 80 containing agents
  • Current or planned treatment with strong inhibitors or inducers of cytochrome P450.
  • Less than 3 weeks since the last treatment of chemotherapy, biological therapy, and/or immunotherapy
  • Leptomeningeal carcinomatosis
  • Contra-indication to contrast-enhanced MRI

Information from the National Library of Medicine

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): NCT01913067


Locations
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Belgium
Institut Jules Bordet
Brussels, Belgium, 1000
Sponsors and Collaborators
Jules Bordet Institute
Sanofi
Investigators
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Principal Investigator: Ahmad Awada, MD, PhD Institute Jules Bordet

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Responsible Party: Jules Bordet Institute
ClinicalTrials.gov Identifier: NCT01913067     History of Changes
Other Study ID Numbers: CE2100
2012-005194-32 ( EudraCT Number )
First Posted: July 31, 2013    Key Record Dates
Last Update Posted: July 24, 2014
Last Verified: July 2014

Keywords provided by Jules Bordet Institute:
brain metastasis
breast cancer
HER2 negative
NSCLC

Additional relevant MeSH terms:
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Breast Neoplasms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
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
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases