Ovarian Cancer Clinical Trial
Official title:
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
RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes
necessary for cancer cell growth.
PURPOSE: Phase II trial to determine the effectiveness of imatinib mesylate in treating
patients who have refractory or relapsed ovarian epithelial, fallopian tube, or primary
peritoneal cancer, or ovarian low malignant potential tumor.
OBJECTIVES:
- 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
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