Status:
COMPLETED
Study of Patupilone in Patients With Brain Metastasis From Non-small Cell Lung Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Brain Metastasis
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 16 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00219297
Start Date
November 16 2005
End Date
June 24 2010
Last Update
February 21 2021
Active Locations (12)
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1
University of California Davis Cancer Center UC Davis Cancer (3)
Sacramento, California, United States, 95817
2
Dana Farber Cancer Institute SC
Boston, Massachusetts, United States, 02115
3
Wayne State University/Wertz Clinical Cancer Center Div. of Hematology/Oncology
Detroit, Michigan, United States, 48201
4
St Louis University Cancer Center
St Louis, Missouri, United States, 63110