Erlotinib,Radiation and Cisplatin in Patients With Complete Resected Squamous Cell Carcinoma of the Head and Neck

Sponsor
Grupo de Investigación Clínica en Oncología Radioterapia
Study ID
NCT00442455
Phase
PHASE3
Status
Completed

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib chlorhydrate — DRUG
    150 mg/day for 7 weeks
  • Cisplatin — DRUG
    30 mg/m2 i.v. weekly for 7 weeks
  • Radiation therapy — PROCEDURE
    63 Gy, five days a week, for 7 weeks

Study Details

The purpose of the study is to determinate the free-progression interval in patients with surgically resected locally advanced squamous cell carcinoma of head and neck treated with the maximum tolerated dose of the combination of erlotinib, radiation therapy and cisplatin, previously established in a safety trial.

Key Dates

First listed
Mar 2, 2007
Start date
Jan 31, 2006
Status verified
May 2019
Primary completion
Aug 31, 2015
Completion
Aug 31, 2015

Study Design

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

Arms

  • Experimental: Erlotinib, radiotherapy.
    There are three cohorts of patients in whom the dose of Erlotinib chlorhydrate(100 and 150 mg) and Cisplatin (30 and 40 mg / m2) will be increase, and the doses of Radiation therapy being fixed (63 Gy during 5 days a week during 7 weeks)

Primary Outcome Measure

Determinate the maximum tolerated dose (PHASE I) [ Time Frame: 17/MAR/08 ]

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