Randomized RT +/- Lapatinib for Advanced Solid Tumor Cancer Patients Receiving Radiation Therapy for Metastatic Disease

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT01427322
Phase
EARLY_PHASE1
Status
Terminated

Conditions

  • Epithelial Cancer

Eligibility Criteria

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

Interventions

  • Lapatinib — DRUG
    given orally 2-4 hours before first fraction of radiation therapy
  • Radiation therapy — RADIATION
    Standard radiation therapy

Study Details

Lapatinib will prevent radiation-induced increase in Transforming Growth Factor alpha (TGFα), an important growth factor in cancer cell recovery after ionizing irradiation.

Key Dates

Start date
Sep 30, 2011
Status verified
Jul 2015
Primary completion
Dec 31, 2014
Completion
Jul 31, 2015

Study Design

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

Arms

  • Experimental: lapatinib + radiation therapy
    lapatinib given orally 2-4 hours prior to first fraction of radiation
  • Active Comparator: No therapy prior to radiation
    Radiation therapy alone

Primary Outcome Measure

TGFalpha [ Time Frame: 3 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Hunter Holmes McGuire VA Medical CenterRichmondVirginia23249-
Massey Cancer Center, Virginia Commonwealth UniversityRichmondVirginia23298-0037-

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By research site
Hunter Holmes McGuire VA Medical Center· Richmond, VAMassey Cancer Center, Virginia Commonwealth University· Richmond, VA