Brain Metastasis, Non-small Cell Lung Cancer
Conditions
Keywords
EPO, EPO906, Brain cancer, Brain metastasis, Lung cancer, Lung metastasis, Brain metastasis from non-small cell lung cancer
Brief summary
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.
Interventions
DRUGPatupilone
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK) of patupilone in blood | throughout the study |
| Time to progression of the brain metastases | throughout the study |
Countries
United States
Outcome results
None listed