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

Novartis

Status and phase

Completed

Phase 2

Conditions

Brain Metastasis

Non-small Cell Lung Cancer

Treatments

Drug: Patupilone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00219297

CEPO906A2227

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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