Gefitinib in Treating Patients Who Are Undergoing Surgery and/or Radiation Therapy for Locally Advanced or Recurrent Squamous Cell Skin Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

March 31, 2005

Primary Completion Date

February 28, 2013

Study Completion Date

February 28, 2013

Conditions
Recurrent Skin CancerSquamous Cell Carcinoma of the Skin
Interventions
DRUG

Gefitinib

Oral Gefitinib induction therapy given daily for 2 months at 250 mg/day, once a day for 30 days (1 cycle = 30 days) with at least 2 cycles of treatment (60 days) given. After 2 months evaluate for clinical response (15 days) and resectability (60 days). If after 15 days with no tumor response, daily dose doubled (500 mg), and discontinuation if tumor progression.

RADIATION

Radiotherapy

Undergo radiation therapy treatments once a day Monday through Friday for about 7 weeks. Each treatment takes about 15 minutes.

PROCEDURE

Conventional surgery

Undergo surgery

OTHER

laboratory biomarker analysis

Correlative studies

Trial Locations (1)

77030

M D Anderson Cancer Center, Houston

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT00126555 - Gefitinib in Treating Patients Who Are Undergoing Surgery and/or Radiation Therapy for Locally Advanced or Recurrent Squamous Cell Skin Cancer | Biotech Hunter | Biotech Hunter