Lapatinib and Radiation for Stage III-IV Head and Neck Cancer Patients Who Cannot Tolerate Concurrent Chemotherapy

Part of paid clinical trials in Stanford, California.

Sponsor
Quynh-Thu Le
Study ID
NCT00490061
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Lapatinib — DRUG
    1500 mg po daily orally
  • Radiotherapy (radiation) — PROCEDURE
    Standard of Care
  • G.E. Healthcare 1.5T MR, systems revision 12.0 M5 — DEVICE
    Standard of Care, used to deliver IMRT
  • DCE-MRI — DEVICE
    A subset of patients received imaging before and after Lapatinib loading, prior to starting radiotherapy.

Study Details

We propose to combine lapatinib with RT alone in patients with locally advanced head and neck cancer who cannot tolerate chemotherapy. The main objective of the study is to determine the efficacy of combining concurrent radiation and lapatinib in terms of time-to-progression (TTP) in this group of patients. In addition, we will determine the 2-year locoregional control rate (LRC), progression-free survival (PFS) and overall survival (OS) in these patients. We will also evaluate the profile and frequency of late toxicity, specifically mucosal and dermatologic toxicity, of the combination of lapatinib and RT in patients with locally advanced head and neck squamous cell carcinoma (HNSCC).

Key Dates

Start date
Jul 31, 2007
Status verified
Jan 2017
Primary completion
Jan 31, 2013
Completion
Jun 30, 2016

Study Design

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

Arms

  • Experimental: Radiotherapy and Lapatinib with DCE-MRI
    DCE-MRI will precede radiotherpy before and after Lapatinib loading. 1500mg/d once daily oral Lapatinib will be administration for seven days prior to and throughout radiotherapy. Radiotherapy will be delivered as Intensity Modulated Radio Therapy (IMRT) using a G.E. Healthcare 1.5T MR, systems revision 12.0 M5 for a total dose of 70Gy delivered in 2-2.12 Gy/ fraction over the course of 6.5-7 weeks.

Primary Outcome Measure

Progression Free Survival [ Time Frame: 2 year PFS: PFS at 2 yrs after study enrollment ]

Locations (5)

FacilityCityStateZIPSite coordinators
Stanford University School of MedicineStanfordCalifornia94305-
University of Florida Shands Cancer CenterGainsvilleFlorida32610-
Beth IsraelNew YorkNew York10003-
Duke UniversityDurhamNorth Carolina27710-
University of Wisconsin Cancer CenterMadisonWisconsin53792-

Find similar trials in Stanford, CA

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Stanford University School of Medicine· Stanford, CAUniversity of Florida Shands Cancer Center· Gainsville, FLBeth Israel· New York, NYDuke University· Durham, NCUniversity of Wisconsin Cancer Center· Madison, WI

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