Sorafenib for Patients With Metastatic or Recurrent Esophageal and Gastroesophageal Junction Cancer
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.
Gastroesophageal Junction Cancer
Drug: Sorafenib, administered orally
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Sorafenib for Patients With Metastatic or Recurrent Esophageal and Gastroesophageal Junction Cancer|
- To evaluate the 2-month progression-free survival (PFS) of sorafenib in patients with metastatic or recurrent esophageal and gastroesophageal (GE) junction cancer. [ Time Frame: after the first 4 weeks on study, at eight weeks, and then every 8 weeks thereafter ] [ Designated as safety issue: No ]
- To evaluate the overall response rate (partial response and complete response) of sorafenib. [ Time Frame: after the first four weeks of therapy, at eight weeks, and every eight weeks thereafter ] [ Designated as safety issue: No ]
- To evaluate the tolerability and adverse event profile of sorafenib in this patient population. [ Time Frame: every week while on study ] [ Designated as safety issue: Yes ]
- To perform an exploratory analysis of differential response between squamous cell carcinoma and adenocarcinoma. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To evaluate phosphorylated extracellular signal-regulated kinase (pERK) expression in tumor tissue and correlate with tumor response. [ Time Frame: anytime prior to enrollment or during protocol therapy ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Sorafenib for patients with metastatic or recurrent esophageal and gastroesophageal junction cancer.
Drug: Sorafenib, administered orally
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.Procedure: CT/MRI
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00917462
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||David Ilson, MD||Memorial Sloan Kettering Cancer Center|