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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.

Phase 2
18 Years
Not Enrolling
Brain Metastasis, Non-small Cell Lung Cancer

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Trial Information

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.

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

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)

Outcome Time Frame:

throughout the study

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

November 2005

Completion Date:

June 2010

Related Keywords:

  • Brain Metastasis
  • Non-Small Cell Lung Cancer
  • EPO
  • EPO906
  • Brain cancer
  • Brain metastasis
  • Lung cancer
  • Lung metastasis
  • Brain metastasis from non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Brain Neoplasms



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Cleveland Clinic Foundation Cleveland, Ohio  44195
Roswell Park Cancer Institute Buffalo, New York  14263
University of Wisconsin Hospital and Clinics Madison, Wisconsin  53792-0001
St. Louis University Cancer Center St. Louis, Missouri  63110
Washington University School Of Medicine-Siteman Cancer Ctr St. Louis, Missouri  63110
Dana Farber Cancer Institute SC Boston, Massachusetts  02115
University of California Davis Cancer Center Dept. of UC Davis Cancer (3) Sacramento, California  95817
Wayne State University/Wertz Clinical Cancer Center Div. of Hematology/Oncology Detroit, Michigan  48201
Dartmouth Hitchcock Medical Center Oncology Lebanon, New Hampshire  03756
Columbia University Medical Center- New York Presbyterian New York, New York  10032
Duke University Medical Center Dept. of DUMC (3) Durham, North Carolina  27710