At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed squamous cell carcinoma of skin that is locally advanced or recurrent, confirmed by MDACC Pathology Department if biopsy from outside institution
- ✓Measurable disease (tumors ≥2 cm in size OR histological/cytological evidence of muscle, bone, lymph node metastasis, or perineural involvement)
- ✓ECOG performance status ≤2 (Karnofsky ≥60%)
- ✓Adequate bone marrow function: leukocytes ≥3000/mm³, ANC ≥1500/mm³, platelets ≥100,000/mm³
- ✕Prior radiotherapy to the proposed site of skin cancer
- ✕Active cancers other than skin cancer
- ✕History of brain metastases
- ✕Distant metastatic disease as determined by diagnostic imaging or hematologic assessments
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of ZD1839 and Radiation in Patients With Squamous Cell Carcinoma of the Skin
In Brief
A Phase 2 clinical trial evaluating Gefitinib, Radiotherapy, and 2 other interventions for Recurrent Skin Cancer and Squamous Cell Carcinoma of the Skin. Completed, enrolled 23 participants across 1 site.
Detailed 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
Study Details
Timeline
Interventions
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.
Undergo radiation therapy treatments once a day Monday through Friday for about 7 weeks. Each treatment takes about 15 minutes.
Undergo surgery
Correlative studies