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

• Status: Completed
• Trial end date: 2010-06-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Epothilone B; Epothilones

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