Sorafenib is a drug being studied for the treatment of cancer. Sorafenib has been shown to block certain proteins on the surface of some cancer cells called "growth factor receptors." Blocking these growth factor receptors can slow or stop cancer cell growth. Sorafenib is also known as Nexavar®. It has been studied in other types of cancers, including kidney cancer, and has been approved by the Food and Drug Administration (FDA) for treating advanced kidney cancer. Because it is not approved by the FDA for treating esophageal cancer, it is considered an experimental treatment. The purpose of this study is to determine what effects sorafenib has on advanced esophageal cancer. These effects include whether sorafenib can shrink the tumor or slow down its growth and what side effects sorafenib will have on the tumor.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Sorafenib 400 mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days. The cycle start date will coincide with the physician visit date. Because of the potential need for physician visit scheduling to vary (due to both physician and patient issues), to avoid violation of, and deviation from, the protocol, these visits may vary by up to one to fourteen (1-14) days. A study diary will be completed by patients to ensure compliance with the study drug.
A CT (computerized tomography) or MRI (magnetic resonance imaging) scan of the chest and abdomen will be obtained at baseline, after the first four weeks of therapy, at eight weeks, and then every eight weeks there afterwith a scheduling window of up to one to fourteen (1-14) days. The same imaging modality performed at baseline (CT or MRI) will be repeated at subsequent imaging.
Memorial Sloan Kettering Cancer Center
New York, New York, United States
2-month Progression-free Survival (PFS) of Sorafenib in Patients With Metastatic or Recurrent Esophageal and Gastroesophageal (GE) Junction Cancer.
Time frame: 2 months
Overall Response Rate (Partial Response and Complete Response) of Sorafenib.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: after the first four weeks of therapy, at eight weeks, and every eight weeks thereafter, an average of 1 year
Number of Participants With Adverse Events
Time frame: every week while on study
Exploratory Analysis of Differential Response Between Squamous Cell Carcinoma and Adenocarcinoma.
Time frame: 2 years
Percentage of Tumors With High Phosphorylated Extracellular Signal-regulated Kinase Expression
Time frame: anytime prior to enrollment or during protocol therapy
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