Study of Patupilone in Patients With Brain Metastasis From Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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The study objective is to evaluate the safety and efficacy of patupilone with respect to early progression and response of patients with non-small cell lung cancer (NSCLC) metastatic to the brain, who have progressed after chemotherapy, surgery and/or radiation.

Official Title
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An Open-label, Multi-center, Phase II Study to Evaluate the Activity of Patupilone (EPO906), in the Treatment of Recurrent or Progressive Brain Metastases in Patients With Non-small Cell Lung Cancer.

Conditions
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Brain Metastasis, Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Patupilone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: World Health Organization (WHO) performance status of 0, 1 or 2 (corresponding to Karnofsky performance status of 50 or better) Patients with radiologically proven (by gadolinium-enhanced [Gd-] magnetic resonance imaging [MRI]) parenchymal brain metastases from histologically confirmed non-small cell lung cancer (the primary disease may be quiescent). Gd-MRI must be performed within 2 weeks of study entry. Patients should have at least one bidimensionally measurable intracranial lesion of a minimum of 2 cm as defined by Gd-MRI. If the patient has had previous radiation to the marker lesion(s), there must be evidence of residual disease > 2 cm or the lesion must have demonstrated progression since the radiation. Those patients progressing on radiotherapy must have a 25% increase in the size of the previously radiated intracranial lesion based on the Neuro-Oncology Criteria of Tumor Response for Central Nervous System (CNS) Tumors or appearance of new lesions. Patients must be controlled on medication and neurologically stable: stable on steroids and anticonvulsants for at least 2 weeks prior to obtaining the baseline Gd-MRI of the brain, and/or at least 2 weeks prior to beginning study treatment. Female patients must have a negative serum pregnancy test at screening. (Not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal.) All patients of reproductive potential must agree to use an effective method of contraception during the study and for three months following termination of treatment. Written informed consent must be obtained. Exclusion Criteria: Clinical evidence of leptomeningeal disease Patients with extracranial disease in more than 3 organ sites including the primary tumor. Patients who have received any investigational compound within the past 28 days or who are planning to receive other investigational drugs while participating in the study Prior administration of epothilone(s) Patients with peripheral neuropathy > grade 1 Patients with unresolved diarrhea within the last 7 days before treatment. Patients receiving known diarrheogenic agents must stop treatment with these agents prior to enrollment in the study. Radiotherapy < 3 weeks prior to study entry Prior intracranial surgery < 3 weeks prior to study entry; patient must have recovered from surgery prior to study entry. Chemotherapy < 3 weeks prior to study entry; < 6 weeks from prior nitrosoureas. Severe cardiac insufficiency (New York Heart Association [NYHA] III or IV), with uncontrolled and/or unstable cardiac or coronary artery disease Radiotherapy not permitted while on study. Exception: palliative radiotherapy of metastasis in extremities is allowed, but such lesions cannot be used as target or non-target lesions. Patients receiving hematopoietic growth factors except for erythropoietin Patients taking Coumadin® or other agents containing warfarin, with the exception of low dose Coumadin® (1 mg or less daily) administered prophylactically for maintenance of in-dwelling lines or ports

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br> | Drug: Patupilone<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST) |  | throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression of the brain metastases |  | throughout the study | 
| Pharmacokinetics (PK) of patupilone in blood |  | throughout the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EPO, EPO906, Brain cancer, Brain metastasis, Lung cancer, Lung metastasis, Brain metastasis from non-small cell lung cancer