Study of Patupilone in Patients With Brain Metastasis From Non-small Cell Lung Cancer
NCT ID: NCT00219297
Last Updated: 2021-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2005-11-16
2010-06-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
Patupilone
Interventions
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Patupilone
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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University of California Davis Cancer Center UC Davis Cancer (3)
Sacramento, California, United States
Dana Farber Cancer Institute SC
Boston, Massachusetts, United States
Wayne State University/Wertz Clinical Cancer Center Div. of Hematology/Oncology
Detroit, Michigan, United States
St Louis University Cancer Center
St Louis, Missouri, United States
Washington University School of Medicine-Siteman Cancer Ctr
St Louis, Missouri, United States
Dartmouth Hitchcock Medical Center Oncology
Lebanon, New Hampshire, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Columbia University Medical Center New York Presbyterian
New York, New York, United States
Duke University Medical Center Dept. of DUMC (3)
Durham, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Countries
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Related Links
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Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.
Other Identifiers
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CEPO906A2227
Identifier Type: -
Identifier Source: org_study_id
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