NCT00702884

Sunitinib in Treating Patients With Relapsed or Refractory Esophageal or Gastroesophageal Junction Cancer

A Mechanistic Radiographic and Biologic Phase 2 Single Agent Study of Sunitinib Malate in Relapsed/Refractory Esophageal and Gastroesophageal Cancers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Tony Bekaii-Saab · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * To determine the progression-free survival rate (complete response, partial response, and stable disease as defined by RECIST criteria \[Response Evaluation Criteria in solid Tumors\]) at 24 weeks in patients with relapsed or refractory esophageal or gastroesophageal junction cancer treated with sunitinib malate. Secondary * To explore the predictive role of a hybrid imaging protocol that combines PET/CT (Positron emission tomography) 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.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	sunitinib malate	Sunitinib 37.5 mg daily for a 4 week cycle

Timeline

• Start date: 2008-06-30
• Primary completion: 2013-09-17
• Completion: 2013-12-30
• First posted: 2008-06-20
• Last updated: 2017-03-21
• Results posted: 2017-03-21

Locations

1 site across 1 country: United States