Oral HYCAMTIN Plus Whole Brain Radiation Therapy In Treatment Of Brain Metastases Resulting From Non-Small Lung Cancer


Tracking Information

Start Date  ICMJEDecember 2006
Estimated Primary Completion DateMarch 2009   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2008)		All-cause mortality
Original Primary Outcome Measures ICMJE 
 (submitted: October 19, 2006)		Overall survival
Change HistoryComplete list of historical versions of study NCT00390806 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: January 30, 2008)
  • Lesion assessment and measurement (baseline; Day 21, Day 28 of both phases) Brain tumor symptom assessment (baseline; Day 1 - 28 of both phases) Adverse events Laboratory tests Disease-related events or outcomes
  • 6-month survival rate
  • response rate [central nervous system (CNS)-radiologic]
  • time to response (CNS-radiologic)
  • time to progression (CNS-radiologic)
  • time to progression (all sites-radiologic)
  • safety and tolerability
Original Secondary Outcome Measures ICMJE 
 (submitted: October 19, 2006)		Response rate Time to clinical progression Safety Time to neurological progression Neurological symptoms

Descriptive Information

Brief Title  ICMJEOral HYCAMTIN Plus Whole Brain Radiation Therapy In Treatment Of Brain Metastases Resulting From Non-Small Lung Cancer
Official Title  ICMJEA 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.
Brief Summary

The current prognosis for patients with metastatic brain cancer from NSCLC is very poor. The current standard treatment for this disease is radiation therapy to the brain. The goal of the current study is to test whether the combination of orally administered HYCAMTIN capsules and whole brain radiation therapy will prolong the survival time of patients with this potentially serious condition.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Parallel Assignment
Condition  ICMJEBrain Metastases From Non-small Cell Lung Cancer
Intervention  ICMJEDrug: HYCAMTIN, oral capsules
Other Name: HYCAMTIN, oral capsules
Study Arms / Comparison Groups 

Recruitment Information

Estimated Enrollment  ICMJE675
Estimated Completion DateMarch 2009
Estimated Primary Completion DateMarch 2009   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • At least one measurable cancerous lesion in the brain from primary non-small cell lung cancer (NSCLC)
  • Must have received previous chemotherapy

Exclusion criteria:

  • Previous whole brain radiation therapy
  • Pregnant or intending to become pregnant or intending to father a baby
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: US GSK Clinical Trials Call Center877-379-3718
Location Countries  ICMJEUnited States,   Canada,   Hungary,   Poland,   Russian Federation,   Slovakia

Administrative Information

NCT ID  ICMJENCT00390806
Responsible PartyStudy Director, GSK
Study ID Numbers  ICMJEHYT105962
Study Sponsor  ICMJEGlaxoSmithKline
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:GSK Clinical Trials, MDGlaxoSmithKline
Information Provided ByGlaxoSmithKline