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Study of Patupilone in Patients With Brain Metastasis From Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified by Novartis, November 2008
Sponsored by: Novartis Pharmaceuticals
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00219297
  Purpose

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 Intervention Phase
Brain Metastasis
Non-Small Cell Lung Cancer
Drug: Patupilone
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Epothilone B
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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.

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression of the brain metastases [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Pharmacokinetics (PK) of patupilone in blood [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: November 2005
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00219297

Contacts
Contact: Novartis Pharmaceuticals +1-800-340-6843

Locations
United States, District of Columbia
Georgetown University/Lombardi Cancer Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Patricia Dunn     202-687-1569     pcd7@georgetown.edu    
Principal Investigator: Shakun Malick, M.D.            
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jennifer Zimmerman     617-632-6684     jennifer_zimmerman@dfci.harvard.edu    
Principal Investigator: Patrick Wen, Dr.            
United States, Missouri
St. Louis University Cancer Center Recruiting
St. Louis, Missouri, United States, 63110
Contact: Lynne Klipsch     314-268-7059     klipschm@slu.edu    
Principal Investigator: Hans Joachim Reimers, Dr.            
Dartmouth-Hitchcock Medical Center Recruiting
St. Louis, Missouri, United States, 03756
Contact: Ian Williams, Mr.     603-650-7966     ian.r.williams@dartmouth.edu    
Principal Investigator: James Rigas, Dr.            
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Kristina Williams     314-362-6963        
Principal Investigator: Ramaswamy Govindan, Dr.            
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Chandra Casas     646-227-2267     casasc@mskcc.org    
Principal Investigator: Laura Abrey, Dr.            
United States, Washington
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98104
Contact: Dione Pedersen     206-386-2444     dione.pedersen@swedish.org    
Principal Investigator: Howard J West, Dr.            
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98119
Contact: Dione Pedersen     206-386-2444     dione.pedersen@swedish.org    
Principal Investigator: Howard J West, Dr.            
United States, Wisconsin
U. of Wisconsin Hospitals and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Diana Trask     608-263-9528     trask@humonc.wisc.edu    
Principal Investigator: H. Ian Robins, M.D.            
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Brain Metastatis from Lung Cancer  This link exits the ClinicalTrials.gov site

Responsible Party: Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers: CEPO906A2227
Study First Received: September 21, 2005
Last Updated: November 17, 2008
ClinicalTrials.gov Identifier: NCT00219297  
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
EPO
EPO906
Brain cancer
Brain metastasis
Lung cancer
Lung metastasis
Brain metastasis from non-small cell lung cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Epothilone B
Non-small cell lung cancer
Epothilones
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Recurrence
Carcinoma
Brain Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasm Metastasis
Carcinoma, Non-Small-Cell Lung
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nervous System Diseases
Mitosis Modulators
Antimitotic Agents
Pharmacologic Actions
Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on January 15, 2009