Lapatinib and WBRT for Patients With Brain Metastases From Lung or Breast Tumors

Sponsor
Hellenic Cooperative Oncology Group
Study ID
NCT01218529
Phase
PHASE2
Status
Completed

Conditions

  • Brain Metastases
  • Breast Tumors
  • Lung Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lapatinib — DRUG
    Co-administration of lapatinib 1250mg once daily during the WBRT period (2 weeks)and then monotherapy with lapatinib 1500mg once daily for 4 weeks.

Study Details

This phase II open-label study will be performed to evaluate the response rate of brain metastases from lung and breast tumors under treatment with WBRT and lapatinib.

Key Dates

Start date
Oct 31, 2010
Status verified
Dec 2014
Primary completion
Aug 31, 2014
Completion
Dec 31, 2014

Study Design

Enrollment
82 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Whole Brain Radiation Therapy (WBRT) + lapatinib
    Whole Brain Radiation Therapy (30Gy in 10 fractions) and lapatinib 1250mg once daily for 2 weeks followed by lapatinib treatment 1500mg once daily for 4 weeks.

Primary Outcome Measure

Response rate in brain as assessed by volumetric analysis of brain Mangnetic Resonance Imaging (MRI). [ Time Frame: At the 6 weeks timepoint, radiological assessment with brain MRI will take place to evaluate the response of the patients ]

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