Status:
WITHDRAWN
Evaluation of Cabazitaxel in Patients With Brain Metastasis Secondary to Breast Cancer and NSCLC
Lead Sponsor:
Jules Bordet Institute
Collaborating Sponsors:
Sanofi
Conditions:
Brain Metastasis
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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-s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01913067
Start Date
September 1 2013
End Date
September 1 2016
Last Update
July 24 2014
Active Locations (1)
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1
Institut Jules Bordet
Brussels, Brussels Capital, Belgium, 1000