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

Breast Cancer Clinical Trial

— CRANIAL  

Official title:

A Phase II Evaluating Cabazitaxel in Patients With Brain Metastasis Secondary to Breast and Non-small Cell Lung Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01913067
• Other study ID #: CE2100
• Secondary ID: 2012-005194-32
• Status: Withdrawn
• Phase: Phase 2
• First received: July 18, 2013
• Last updated: July 23, 2014
• Start date: September 2013
• Est. completion date: September 2016

Study information

• Verified date: July 2014
• Source: Jules Bordet Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Metastasis
• Brain Neoplasms
• Breast Cancer
• Breast Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Neoplasm Metastasis
• Non Small Cell Lung Cancer

Intervention

Drug:
• Cabazitaxel
Intravenous, 25 mg/m2 every 3 weeks

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

Locations

Country	Name	City	State
Belgium	Institut Jules Bordet	Brussels

Sponsors (2)

Lead Sponsor	Collaborator
Jules Bordet Institute	Sanofi

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of brain lesions.	Objective response defined as a >= 50% volumetric reduction of brain lesions in the absence of increasing steroid use and progressive neurologic symptoms.	week 6	No
Secondary	Time to whole brain irradiation or radiosurgery	Determine the effect of cabazitaxel on the time to initiating whole brain irradiation or radiosurgery	every 6 weeks until disease progression.	No
Secondary	Time to developing neurological symptoms.	Determine the effect of cabazitaxel on the time to developing neurological symptoms	every 6 weeks until disease progression.	No
Secondary	Time to progression in the brain	Determine the effect of cabazitaxel on the time to disease progression in the brain.	every 6 weeks until disease progression.	No
Secondary	Time to progression extra-cranial	Determine the effect of cabazitaxel on the time to disease progression outside the brain	every 6 weeks until disease progression.	No
Secondary	Toxicity	Determine the safety of cabazitaxel	every 3 weeks until 30 days after last treatment administration.	Yes