NCT00126555

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

A Phase II Study of ZD1839 and Radiation in Patients With Squamous Cell Carcinoma of the Skin

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical research study is to learn if giving Iressa (Gefitinib or ZD1839) with surgery and/or radiation will help to control squamous cell carcinoma of the skin. The safety of this treatment will also be studied

Detailed description

PRIMARY OBJECTIVES: I. Early progression rate (progression during ZD1839 induction). II. Feasibility of induction ZD1839 (for all patients) and concomitant ZD1839 with radiotherapy (for unresectable patients). III. Toxicities of induction ZD1839 (for all patients) and concomitant ZD1839 with radiotherapy (for unresectable patients). SECONDARY OBJECTIVES: I. Response: clinical responses to induction therapy. II. Failures: frequency and timing of local and distant failures. III. Biomarkers: biomarker levels in tumor and normal tissue. TERTIARY OBJECTIVES: I. For progressive disease responders, patients will be followed for locoregional and distant metastases data. II. Feasibility of maintenance ZD1839. III. Toxicities of maintenance ZD1839. OUTLINE: Patients are assigned to 1 of 2 groups. STRATUM I (initially resectable tumor): Patients undergo radiotherapy once daily (QD) 5 days a week for approximately 6-7 weeks. Patients also receive gefitinib orally (PO) QD for up to 12 months STRATUM II (initially unresectable tumor): Patients undergo radiotherapy QD 5 days a week for approximately 6-7 weeks. Patients also receive concurrent gefitinib PO QD for 6-7 weeks. Patients then undergo surgery. After surgery, patients receive gefitinib PO QD for up to 12 months. After completion of study treatment, patients are followed up for up to 5 years.

Conditions

• Recurrent Skin Cancer
• Squamous Cell Carcinoma of the Skin

Interventions

Type	Name	Description
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

Timeline

• Start date: 2005-03-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2005-08-04
• Last updated: 2019-08-30
• Results posted: 2014-12-24

Locations

1 site across 1 country: United States