study of patupilone in patients with brain metastasis from non-small cell lung cancer

Conditions: Brain Metastasis; Non-small Cell Lung Cancer

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.


Eligibility criteria:
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

Keywords: epo epo906 brain cancer brain metastasis lung cancer lung metastasis brain metastasis from non-small cell lung cancer