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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00219297
First received: September 21, 2005
Last updated: March 14, 2013
Last verified: March 2013
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


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 ]

Enrollment: 62
Study Start Date: November 2005
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: Patupilone

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219297

Locations
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
Washington University School of Medicine-Siteman Cancer Ctr
St. Louis, Missouri, United States, 63110
St. Louis University Cancer Center
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
Columbia University Medical Center- New York Presbyterian
New York, New York, United States, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10022
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
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00219297     History of Changes
Other Study ID Numbers: CEPO906A2227
Study First Received: September 21, 2005
Last Updated: March 14, 2013
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

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
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
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014