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A Randomized, Phase III, Open-Label Study of Oral Topotecan Plus Whole-Brain Radiation Therapy (WBRT) Compared With WBRT Alone in Patients With Brain Metastases From Non-Small Cell Lung Cancer

Phase 3
18 Years
Open (Enrolling)
Lung Cancer, Non-Small Cell

Thank you

Trial Information

A Randomized, Phase III, Open-Label Study of Oral Topotecan Plus Whole-Brain Radiation Therapy (WBRT) Compared With WBRT Alone in Patients With Brain Metastases From Non-Small Cell Lung Cancer

Inclusion Criteria

Inclusion criteria:

- At least one measurable cancerous lesion in the brain from primary non-small cell
lung cancer (NSCLC)

- Must have received previous chemotherapy

- Must be 18 years of age of greater

- Must be Easter Cooperative Oncology Group (ECOG) Performance Status 0, 1, 2

- At least 2 weeks must have elapsed since any surgery

- At least 4 weeks must have elapsed since any radiation to a non-CNS site

- Must have adequate bone marrow, renal, and live capacities

- Women must be of non-childbearing potential or practice adequate birth control

- Males must practice adequate methods of birth control

- Must sign written informed consent

Exclusion criteria:

- Previous whole brain radiation therapy

- Prior treatment with topotecan

- Investigational agent within 30 days or 5 half-live

- Concomitant therapy with inhibitors of breast cancer resistance protein (BCRP) or
P-glycoprotein such as erlotinib or gefitinib

- Primary or secondary immunodeficiencies

- Gastrointestinal conditions that affect GI absorption or motility

- Uncontrolled emesis

- Brain metastasis at time of initial diagnosis of NSCLC

- History of other malignancy except in situ carcinoma of cervix; nonmelanomatous skin
cancer, low grade prostate cancer

- Pregnant or intending to become pregnant or intending to father a baby

- Any severe concurrent medical condition that could affect compliance.

Type of Study:


Study Design:

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

Outcome Measure:

Overall survival

Outcome Time Frame:

Approximately 5 years

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



Slovakia: State Institute for Drug Control

Study ID:




Start Date:

December 2006

Completion Date:

January 2013

Related Keywords:

  • Lung Cancer, Non-Small Cell
  • Brain metastases from Non-Small Cell Lung Cancer
  • Brain metastases brain tumor lung cancer oral chemotherapy HYCAMTIN topotecan NSCLC WBRT whole brain radiation
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Brain Neoplasms



GSK Investigational Site Phoenix, Arizona  85013 - 4496
GSK Investigational Site Little Rock, Arkansas  72205
GSK Investigational Site Bakersfield, California  93309
GSK Investigational Site Gainesville, Florida  32610
GSK Investigational Site Indianapolis, Indiana  46260
GSK Investigational Site Lexington, Kentucky  40536-0098
GSK Investigational Site New Orleans, Louisiana  70112
GSK Investigational Site Duluth, Minnesota  55805
GSK Investigational Site St. Louis, Missouri  63141
GSK Investigational Site Albuquerque, New Mexico  87109
GSK Investigational Site Akron, Ohio  44304
GSK Investigational Site Fort Worth, Texas  76104
GSK Investigational Site Green Bay, Wisconsin  54301
GSK Investigational Site Park Ridge, Illinois  60068
GSK Investigational Site Columbia, South Carolina  29210
GSK Investigational Site New York, New York  10021
GSK Investigational Site Birmingham, Alabama  35209
GSK Investigational Site Aurora, Colorado  80012
GSK Investigational Site Kansas City, Kansas  66160
GSK Investigational Site Hattiesburg, Mississippi  39401
GSK Investigational Site Omaha, Nebraska  68131
GSK Investigational Site Henderson, Nevada  89014
GSK Investigational Site Oregon City, Oregon  97045
GSK Investigational Site Seattle, Washington  98133