Phase II Clinical Trial With Proteomic Profiling Of Imatinib Mesylate (Gleevec; STI571), A PDGFR And C-Kit Inhibitor, In Patients With Refractory Or Relapsed Epithelial Ovarian Cancer, Fallopian Tube And Primary Peritoneal Cancer
- Determine the clinical activity of imatinib mesylate in patients with recurrent or
relapsed ovarian epithelial, fallopian tube, or primary peritoneal cancer or ovarian
low malignant potential tumor.
- Correlate the biochemical modulation of signal transduction pathways downstream of
platelet-derived growth factor receptor (PDGFR) and c-kit tyrosine kinases in biopsy
tissue with outcome in patients treated with this drug.
- Correlate the expression of PDGFR and c-kit in both archival and fresh biopsy tissue
with response and outcome in patients treated with this drug.
- Investigate the potential antiangiogenic activity of this drug in microdissected tumor
cell and stromal lysates of these patients.
- Investigate the potential for collateral receptor tyrosine kinase inhibition in biopsy
tissue of patients treated with this drug.
- Evaluate the application of surface-enhanced laser desorption and ionization with
time-of-flight detection (SELDI-TOF) with artificial intelligence bioinformatics to
serially obtained serum samples for prediction of response in these patients and/or
toxicity of this drug.
OUTLINE: Patients receive oral imatinib mesylate once daily on days 1-28. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Up to 47 patients will be accrued for this study within 12-20 months.
Masking: Open Label, Primary Purpose: Treatment
Clinical response in patients with epithelial ovarian cancer as measured by CT scan of chest, abdomen, and pelvis every 8 weeks
Elise C. Kohn, MD
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|