Conditions: Esophageal Cancer
Keywords: recurrent esophageal cancer stage IIIA esophageal cancer stage IIIB esophageal cancer stage IIIC esophageal cancer stage IV esophageal cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 25
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Sunitinib 37.5 mg daily for a 4 week cycle

Interventions: intervention 1: sunitinib malate
Intervention descriptions: intervention 1: Sunitinib 37.5 mg daily for a 4 week cycle

Protocol document: