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

NCT01913067 | Withdrawn Phase 2

• 2 other identifiers: CE21002012-005194-32
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Brain Metastasis; Breast Cancer; Non Small Cell Lung Cancer

Keywords

brain metastasis; breast cancer; HER2 negative; NSCLC

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Time to whole brain irradiation or radiosurgery

  every 6 weeks until disease progression.

• Time to developing neurological symptoms.

  every 6 weeks until disease progression.

• Time to progression in the brain

  every 6 weeks until disease progression.

• Time to progression extra-cranial

  every 6 weeks until disease progression.

• Toxicity

  every 3 weeks until 30 days after last treatment administration.

Study Arms (1)

Cabazitaxel

EXPERIMENTAL

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; Procedure: Contrast-enhanced whole brain MRI

Interventions

Cabazitaxel DRUG

Intravenous, 25 mg/m2 every 3 weeks

Also known as: Jevtana

Cabazitaxel

Contrast-enhanced whole brain MRI PROCEDURE

Evaluation of the volumetric reduction in the size of the brain lesion(s).

Cabazitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Jules Bordet Institute: lead
• Sanofi: collaborator

Study Sites (1)

Institut Jules Bordet

Brussels, Brussels Capital, 1000, Belgium

Location

MeSH Terms

Conditions

Brain Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

cabazitaxel

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ahmad Awada, MD, PhD

  Institute Jules Bordet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2013
• First Posted: July 31, 2013
• Study Start: September 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: September 1, 2016
• Last Updated: July 24, 2014

Record last verified: 2014-07

Locations

BE (1)