Lapatinib Versus Placebo Given Concurrently With Cisplatin And Radiotherapy In Patients With Unresected Head And Neck Cancer

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
GlaxoSmithKline
Study ID
NCT00387127
Phase
PHASE2
Status
Completed

Conditions

  • Neoplasms, Head and Neck

Eligibility Criteria

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

Interventions

  • Lapatinib oral tablets — DRUG
    Lapatinib is administered orally once daily.
  • radiotherapy — DRUG
    Radiotherapy is given either as conventional fractionation using Two-dimensional (2D) or conformal techniques, or as Intensity Modulated Radiation Therapy (IMRT). Radiation therapy will be standardised throughout the study. Radiation therapy is given only once daily, with a dose/fraction not exceeding 2.5Gy, to a total dose of 65 Gy (IMRT) or 70 Gy (2D or 3D RT) to the gross site of disease .
  • cisplatin chemotherapy — DRUG
    Cisplatin is administered intravenously at a dose of 100mg/m2 on days 1, 22 and 43 of radiotherapy (approximately Study Days 8, 29 and 50).

Study Details

This is a phase II study comparing the effects of lapatinib versus placebo when administered concurrently with cisplatin and radiotherapy followed by 1 year monotherapy with lapatinib or placebo. The study is designed to evaluate and compare the two treatment groups with respect to complete response rate at 6 months following chemoradiation completion.

Key Dates

Start date
Nov 30, 2006
Status verified
Feb 2015
Primary completion
Jun 30, 2009
Completion
Jan 31, 2014

Study Design

Enrollment
67 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lapatinib
    1500mg lapatinib orally daily
  • Placebo Comparator: Placebo
    orally daily

Primary Outcome Measure

Number of Participants (Par.) With Complete Response (CR), as Assessed by Independent Radiological Review [ Time Frame: From the date of randomization until 6 months post chemoradiation treatment, assessed for a median time of 13 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteMinneapolisMinnesota55417-
GSK Investigational SiteKansas CityMissouri64128-
GSK Investigational SiteCharlotteNorth Carolina28203-

Find similar trials in Minneapolis, MN

By research site
GSK Investigational Site· Minneapolis, MNGSK Investigational Site· Kansas City, MOGSK Investigational Site· Charlotte, NC

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