Phase II Pilot Study of Clinical Activity and Proteomic Pathway Profiling of the EGFR Inhibitor, ZD1839 (Iressa; Gefitinib), in Patients With Epithelial Ovarian Cancer or Cervical Cancer
- Determine the reduction in phosphorylation of epidermal growth factor receptor (EGFR),
AKT, and ERK by proteomics in tumor and normal skin of patients with ovarian epithelial
cancer or cervical cancer receiving gefitinib. (Open to accrual for cervical cancer
patients only as of 4/5/2005)
- Determine the clinical activity of this drug in these patients.
- Determine the toxicity of this drug in these patients.
- Correlate the biologic modulation of EGFR, ERK, and AKT by this drug with outcome and
toxic effects in these patients.
- Correlate EGFR modulation in skin with outcome and toxic effects in patients treated
with this drug.
- Correlate expression of EGFR and phosphorylated-EGFR in tissue biopsies from these
patients with biochemical modulation and outcome.
- Determine the application of surface-enhanced laser desorption and ionization with
time-of-flight detection (SELDI-TOF) and artificial intelligence bioinformatics to
serially obtained serum samples for predicting response and toxic effects in these
OUTLINE: Patients are stratified according to disease (cervical cancer vs ovarian
epithelial, fallopian tube, and primary peritoneal cancer). (Open to accrual for cervical
cancer patients only as of 4/5/2005)
Patients receive oral gefitinib daily. Treatment continues every 28 days in the absence of
disease progression or unacceptable toxicity.
Biopsies of a sentinel lesion (with CT guidance or laparoscopy) are obtained at baseline and
at 4 weeks. Skin biopsies of unaffected areas are also obtained at these time points. Tissue
is examined using immunohistochemical methods. Proteomic profiling using surface-enhanced
laser desorption/ionization with time-of-flight (SELDI-TOF) mass spectrometry is conducted
on serum at baseline and then every 4 weeks.
Patients are followed monthly.
PROJECTED ACCRUAL: A total of 30-40 patients (15-20 per stratum) will be accrued for this
study within 10-12 months. (Open to accrual for cervical cancer patients only as of
Primary Purpose: Treatment
Biochem. modulation of EGFR signal transduction pathways in tumor by tissue lysate array reduction in phosphorylation of EGFR , AKT, and ERK in tumor biopsies at baseline and at 4 weeks during therapy
Virginia Kwitkowski, MS, RN, CS, CRNP
National Cancer Institute (NCI)
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|
|NCI - Center for Cancer Research||Bethesda, Maryland 20892|