A Mechanistic Radiographic and Biologic Phase 2 Single Agent Study of Sunitinib Malate in Relapsed/Refractory Esophageal and Gastroesophageal Cancers
- To determine the progression-free survival rate (complete response, partial response,
and stable disease as defined by RECIST criteria) at 24 weeks in patients with relapsed
or refractory esophageal or gastroesophageal junction cancer treated with sunitinib
- To explore the predictive role of a hybrid imaging protocol that combines PET/CT scan
simultaneously with dynamic contrast-enhanced MRI.
- Correlate quantitative changes in mean vessel density, alterations in tumor cell
proliferation, and apoptosis in tumor biopsy specimens with clinical outcome in these
- To evaluate the objective response as defined by RECIST criteria, median overall
survival, and median progression-free survival of these patients.
- To evaluate the toxicities of sunitinib malate in these patients.
OUTLINE: Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo blood and tumor tissue sample collection periodically for correlative
laboratory studies. Tumor tissue samples are assessed by immunohistochemistry and TUNEL for
detection and quantitation of mean vessel density, proliferating tumor cells, and apoptosis.
Tumor tissue samples are also assessed by immunohistochemistry for MAPK levels. Blood
samples are analyzed by ELISA for VEGF, PlGF, sVEGFR2, and sVEGFR3 levels. Patients also
undergo PET/CT scan and dynamic contrast-enhanced MRI periodically for correlative studies.
After completion of study treatment, patients are followed for at least 6 months.
Masking: Open Label, Primary Purpose: Treatment
Progression-free survival rate (complete response, partial response, and stable disease) as assessed by RECIST criteria at 24 weeks
Tanios Bekaii-Saab, MD
Ohio State University Comprehensive Cancer Center
|Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center||Columbus, Ohio 43210-1240|