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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
N/A
Open (Enrolling)
Both
Lung Cancer, Non-Small Cell

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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:

Interventional

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:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Slovakia: State Institute for Drug Control

Study ID:

HYT105962

NCT ID:

NCT00390806

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

Name

Location

GSK Investigational SitePhoenix, Arizona  85013 - 4496
GSK Investigational SiteLittle Rock, Arkansas  72205
GSK Investigational SiteBakersfield, California  93309
GSK Investigational SiteGainesville, Florida  32610
GSK Investigational SiteIndianapolis, Indiana  46260
GSK Investigational SiteLexington, Kentucky  40536-0098
GSK Investigational SiteNew Orleans, Louisiana  70112
GSK Investigational SiteDuluth, Minnesota  55805
GSK Investigational SiteSt. Louis, Missouri  63141
GSK Investigational SiteAlbuquerque, New Mexico  87109
GSK Investigational SiteAkron, Ohio  44304
GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SiteGreen Bay, Wisconsin  54301
GSK Investigational SitePark Ridge, Illinois  60068
GSK Investigational SiteColumbia, South Carolina  29210
GSK Investigational SiteNew York, New York  10021
GSK Investigational SiteBirmingham, Alabama  35209
GSK Investigational SiteAurora, Colorado  80012
GSK Investigational SiteKansas City, Kansas  66160
GSK Investigational SiteHattiesburg, Mississippi  39401
GSK Investigational SiteOmaha, Nebraska  68131
GSK Investigational SiteHenderson, Nevada  89014
GSK Investigational SiteOregon City, Oregon  97045
GSK Investigational SiteSeattle, Washington  98133