Sorafenib for Patients With Metastatic or Recurrent Esophageal and Gastroesophageal Junction Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

June 30, 2009

Primary Completion Date

August 31, 2018

Study Completion Date

August 31, 2018

Conditions
Esophageal CancerGastroesophageal Junction Cancer
Interventions
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.

Trial Locations (1)

10065

Memorial Sloan Kettering Cancer Center, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER