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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 CoumadinĀ® or other agents containing warfarin, with the exception of
low dose CoumadinĀ® (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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University of Wisconsin Hospital and Clinics Madison, Wisconsin  53792-0001
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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