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

• Status: Withdrawn
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jules Bordet Institute
• Collaborator: Sanofi

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