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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00219297
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : March 15, 2013
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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 have progressed after chemotherapy, surgery and/or radiation.

Condition or disease Intervention/treatment Phase
Brain Metastasis Non-small Cell Lung Cancer Drug: Patupilone Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multi-center, Phase II Study to Evaluate the Activity of Patupilone (EPO906), in the Treatment of Recurrent or Progressive Brain Metastases in Patients With Non-small Cell Lung Cancer.
Study Start Date : November 2005
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Single Arm Drug: Patupilone

Primary Outcome Measures :
  1. Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: throughout the study ]

Secondary Outcome Measures :
  1. Time to progression of the brain metastases [ Time Frame: throughout the study ]
  2. Pharmacokinetics (PK) of patupilone in blood [ Time Frame: throughout the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00219297

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United States, California
University of California Davis Cancer Center Dept. of UC Davis Cancer (3)
Sacramento, California, United States, 95817
United States, Massachusetts
Dana Farber Cancer Institute SC
Boston, Massachusetts, United States, 02115
United States, Michigan
Wayne State University/Wertz Clinical Cancer Center Div. of Hematology/Oncology
Detroit, Michigan, United States, 48201
United States, Missouri
St. Louis University Cancer Center
St. Louis, Missouri, United States, 63110
Washington University School of Medicine-Siteman Cancer Ctr
St. Louis, Missouri, United States, 63110
United States, New Hampshire
Dartmouth Hitchcock Medical Center Oncology
Lebanon, New Hampshire, United States, 03756
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10022
Columbia University Medical Center- New York Presbyterian
New York, New York, United States, 10032
United States, North Carolina
Duke University Medical Center Dept. of DUMC (3)
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Additional Information:
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT00219297    
Other Study ID Numbers: CEPO906A2227
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: March 15, 2013
Last Verified: March 2013
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Brain cancer
Brain metastasis
Lung cancer
Lung metastasis
Brain metastasis from non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epothilone B
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action