Sunitinib in Treating Patients With Relapsed or Refractory Esophageal or Gastroesophageal Junction Cancer
Recruitment status was Recruiting
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with relapsed or refractory esophageal or gastroesophageal junction cancer.
Drug: sunitinib malate
Genetic: TdT-mediated dUTP nick end labeling assay
Other: immunoenzyme technique
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Procedure: computed tomography
Procedure: dynamic contrast-enhanced magnetic resonance imaging
Procedure: positron emission tomography
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Mechanistic Radiographic and Biologic Phase 2 Single Agent Study of Sunitinib Malate in Relapsed/Refractory Esophageal and Gastroesophageal Cancers|
- Progression-free survival rate (complete response, partial response, and stable disease) as assessed by RECIST criteria at 24 weeks [ Designated as safety issue: No ]
- Overall response rate [ Designated as safety issue: No ]
- Median overall survival time [ Designated as safety issue: No ]
- Median progression-free survival time [ Designated as safety issue: No ]
- Frequency and severity of adverse events [ Designated as safety issue: Yes ]
- Change in mean vessel density [ Designated as safety issue: No ]
- Quantitative assessment of proliferating tumor cells and apoptosis [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
- 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 malate.
- 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 patients.
- 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.
|United States, Ohio|
|Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center||Recruiting|
|Columbus, Ohio, United States, 43210-1240|
|Contact: Tanios Bekaii-Saab, MD 866-627-7616|
|Principal Investigator:||Tanios Bekaii-Saab, MD||Ohio State University Comprehensive Cancer Center|