Capecitabine With or Without Sunitinib Malate as First-Line Therapy in Treating Patients With Metastatic Cancer of the Esophagus or Gastroesophageal Junction
Adenocarcinoma of the Gastroesophageal Junction, Esophageal Cancer
About this trial
This is an interventional treatment trial for Adenocarcinoma of the Gastroesophageal Junction focused on measuring adenocarcinoma of the esophagus, adenocarcinoma of the gastroesophageal junction, recurrent esophageal cancer, stage IV esophageal cancer, stage III esophageal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction
- Metastatic disease
- Unresectable disease with no curative options
- Measurable disease with ≥ 1 lesion whose longest diameter can be accurately measured as ≥ 2.0 cm by conventional techniques or ≥ 1.0 cm by spiral CT
Not a candidate for a conventional multi-drug chemotherapy regimen with fairly standard dosing (i.e., patient is able to tolerate at least 80% of standard dosing)
- Patients who have been offered and declined conventional multi-drug chemotherapy are eligible
- No known CNS metastases
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2 and age ≥ 65 years OR PS 2 and age ≥ 18 years but < 65 years
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Total bilirubin normal
- Alkaline phosphatase ≤ 2 times upper limit of normal (ULN)
- Creatinine ≤ 1.5 times ULN
- Creatinine clearance ≥ 60mL/min
- AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN in the presence of liver metastases)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Willing to provide tissue samples for central review and research purposes
- Able to swallow pills
- No immunocompromised patients (other than related to the use of corticosteroids), including patients known to be HIV-positive
- No co-morbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
No uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situations that would limit compliance with study requirements
- No NYHA class III or IV heart failure
- No uncontrolled hypertension except at the discretion of treating oncologist
- No other active malignancy except for nonmelanoma skin cancer or carcinoma in situ of the cervix
- No known dihydropyrimidine dehydrogenase deficiency (DPD)
PRIOR CONCURRENT THERAPY:
No prior chemotherapy, radiotherapy, immunotherapy, or biological therapy for recurrent or metastatic cancer
- Prior chemotherapy or radiotherapy are allowed if they had been administered as adjuvant or neoadjuvant therapy and a complete surgical resection of the original cancer had been achieved
- No prior sunitinib malate
- No prior radiotherapy to > 30% of the marrow cavity at any time
- More then 4 weeks since prior major surgery
- At least 12 days since prior and no concurrent CYP3A4 inducers, including rifampin, rifabutin, carbamazepine, phenobarbital, phenytoin, St. John's wort, efavirenz, and tipranavir
- At least 7 days since prior and no concurrent CYP3A4 inhibitors, including azole antifungals (ketoconazole, itraconazole), clarithromycin, erythromycin, diltiazem, verapamil, HIV protease inhibitors (indinavir, saquinavir, ritonavir, atazanavir, nelfinavir), and delavirdine
- No other concurrent specific treatment (other than hormonal therapy) in patients with a history of prior malignancy
Sites / Locations
- Mayo Clinic Scottsdale
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
- Mayo Clinic - Jacksonville
- Illinois CancerCare - Bloomington
- St. Joseph Medical Center
- Graham Hospital
- Illinois CancerCare - Canton
- Illinois CancerCare - Carthage
- Memorial Hospital
- Eureka Community Hospital
- Illinois CancerCare - Eureka
- Galesburg Clinic, PC
- Illinois CancerCare - Galesburg
- Illinois CancerCare - Havana
- Mason District Hospital
- Illinois CancerCare - Kewanee Clinic
- Illinois CancerCare - Macomb
- McDonough District Hospital
- Illinois CancerCare - Monmouth
- OSF Holy Family Medical Center
- BroMenn Regional Medical Center
- Community Cancer Center
- Illinois CancerCare - Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Illinois CancerCare - Pekin
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- Methodist Medical Center of Illinois
- OSF St. Francis Medical Center
- Illinois CancerCare - Peru
- Illinois Valley Community Hospital
- Illinois CancerCare - Princeton
- Perry Memorial Hospital
- Illinois CancerCare - Spring Valley
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Reid Hospital & Health Care Services
- Cedar Rapids Oncology Associates
- Mercy Regional Cancer Center at Mercy Medical Center
- Medical Oncology and Hematology Associates - West Des Moines
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas, PA - Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas, PA - Liberal
- Cancer Center of Kansas, PA - Newton
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Cancer Center of Kansas, PA - Wellington
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- Hickman Cancer Center at Bixby Medical Center
- Saint Joseph Mercy Cancer Center
- CCOP - Michigan Cancer Research Consortium
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Foote Memorial Hospital
- Haematology-Oncology Associates of Ohio and Michigan, PC
- Sparrow Regional Cancer Center
- St. Mary Mercy Hospital
- Community Cancer Center of Monroe
- Mercy Memorial Hospital - Monroe
- St. Joseph Mercy Oakland
- Mercy Regional Cancer Center at Mercy Hospital
- Seton Cancer Institute at Saint Mary's - Saginaw
- St. John Macomb Hospital
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Duluth Clinic Cancer Center - Duluth
- CCOP - Duluth
- Miller - Dwan Medical Center
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Hutchinson Area Health Care
- HealthEast Cancer Care at St. John's Hospital
- Minnesota Oncology Hematology, PA - Maplewood
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Hennepin County Medical Center - Minneapolis
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
- Mayo Clinic Cancer Center
- CCOP - Metro-Minnesota
- Park Nicollet Cancer Center
- Regions Hospital Cancer Care Center
- United Hospital
- St. Francis Cancer Center at St. Francis Medical Center
- Ridgeview Medical Center
- Willmar Cancer Center at Rice Memorial Hospital
- Minnesota Oncology Hematology, PA - Woodbury
- Missouri Baptist Cancer Center
- Arch Medical Services, Incorporated at Center for Cancer Care and Research
- CCOP - Montana Cancer Consortium
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare Cancer Care Services
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Billings Clinic - Downtown
- Bozeman Deaconess Cancer Center
- St. James Healthcare Cancer Care
- Great Falls Clinic - Main Facility
- Sletten Cancer Institute at Benefis Healthcare
- Northern Montana Hospital
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology at KRMC
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Cancer Resource Center - Lincoln
- CCOP - Missouri Valley Cancer Consortium
- Immanuel Medical Center
- Alegant Health Cancer Center at Bergan Mercy Medical Center
- Creighton University Medical Center
- Rutherford Hospital
- Bismarck Cancer Center
- Medcenter One Hospital Cancer Care Center
- Mid Dakota Clinic, PC
- St. Alexius Medical Center Cancer Center
- Altru Cancer Center at Altru Hospital
- Wood County Oncology Center
- North Coast Cancer Care - Clyde
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- CCOP - Dayton
- Community Cancer Center
- Hematology Oncology Center
- Blanchard Valley Medical Associates
- Middletown Regional Hospital
- Wayne Hospital
- Charles F. Kettering Memorial Hospital
- Lima Memorial Hospital
- Northwest Ohio Oncology Center
- St. Luke's Hospital
- Fisher-Titus Medical Center
- St. Charles Mercy Hospital
- Toledo Clinic - Oregon
- North Coast Cancer Care, Incorporated
- Flower Hospital Cancer Center
- Mercy Hospital of Tiffin
- Toledo Hospital
- St. Vincent Mercy Medical Center
- Medical University of Ohio Cancer Center
- CCOP - Toledo Community Hospital
- St. Anne Mercy Hospital
- Toledo Clinic, Incorporated - Main Clinic
- UVMC Cancer Care Center at Upper Valley Medical Center
- Fulton County Health Center
- Clinton Memorial Hospital
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Geisinger Cancer Institute at Geisinger Health
- Geisinger Hazleton Cancer Center
- Geisinger Medical Group - Scenery Park
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- AnMed Cancer Center
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Rapid City Regional Hospital
- Avera Cancer Institute
- Medical X-Ray Center, PC
- Sanford Cancer Center at Sanford USD Medical Center
- Fredericksburg Oncology, Incorporated
- Rocky Mountain Oncology
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I
Arm II
Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm II at the physician's discretion.
Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.