Gefitinib in Treating Patients With Locally Advanced Esophageal Cancer
Esophageal Cancer
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring adenocarcinoma of the esophagus, stage II esophageal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction Locally advanced disease T3 or T4 tumor with no lymph node involvement OR any T stage with local lymph node involvement Celiac node involvement allowed No supraclavicular lymph node involvement Received potentially curative chemotherapy, radiotherapy, and/or surgery within the past 1-3 months Patients who received adjuvant chemotherapy or chemoradiotherapy after surgery are eligible provided last treatment was administered within the past 3 months No evidence of residual tumor or metastatic disease after undergoing potentially curative therapy No positive margins at the time of prior surgery No measurable or evaluable disease PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 12 weeks Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin ≤ 2.0 mg/dL Renal Creatinine ≤ 2 times upper limit of normal Cardiovascular No New York Heart Association class III or IV heart disease Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Able to swallow study drug No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics Endocrine therapy Not specified Radiotherapy See Disease Characteristics Surgery See Disease Characteristics Other No prior gefitinib No concurrent CYP3A4 inducing agents, including any of the following: Carbamazepine Oxcarbazepine Modafinil Ethosuximide Griseofulvin Nafcillin Phenobarbital Phenylbutazone Phenytoin Primidone Rifampin Hypericum perforatum (St. John's wort) Sulfinpyrazone No concurrent antacids 4 hours before or after study drug administration
Sites / Locations
- Mobile Infirmary Medical Center
- Mayo Clinic - Jacksonville
- Rush-Copley Cancer Care Center
- St. Joseph Medical Center
- Graham Hospital
- Memorial Hospital
- Eureka Community Hospital
- Galesburg Clinic
- Galesburg Cottage Hospital
- Mason District Hospital
- Hopedale Medical Complex
- Joliet Oncology-Hematology Associates, Limited - West
- Kewanee Hospital
- McDonough District Hospital
- BroMenn Regional Medical Center
- Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Cancer Treatment Center at Pekin Hospital
- 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 Valley Community Hospital
- St. Margaret's Hospital
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Saint Anthony Memorial Health Centers
- Reid Hospital & Health Care Services, Incorporated
- McFarland Clinic, PC
- Cedar Rapids Oncology Associates
- Mercy Capitol Hospital
- 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
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Medical Oncology and Hematology Associates - West Des Moines
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas, PA - Kingman
- Southwest Medical Center
- 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
- Associates in Womens Health, PA - North Review
- 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
- Haematology-Oncology Associates of Ohio and Michigan, PC
- Community Cancer Center of Monroe
- Mercy Memorial Hospital - Monroe
- MeritCare Bemidji
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Hutchinson Area Health Care
- Meeker County Memorial Hospital
- 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
- St. Francis Cancer Center at St. Francis Medical Center
- HealthEast Cancer Care at St. Joseph's Hospital
- Park Nicollet Cancer Center
- Regions Hospital Cancer Care Center
- United Hospital
- Ridgeview Medical Center
- HealthEast Cancer Care at Woodwinds Health Campus
- Minnesota Oncology Hematology, PA - Woodbury
- CCOP - MeritCare Hospital
- MeritCare Broadway
- Wood County Oncology Center
- Grandview Hospital
- Good Samaritan Hospital
- Samaritan North Cancer Care Center
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Blanchard Valley Medical Associates
- Fremont Memorial Hospital
- Kenton Oncology, Incorporated
- Charles F. Kettering Memorial Hospital
- Lima Memorial Hospital
- Northwest Ohio Oncology Center
- St. Luke's Hospital
- Middletown Regional Hospital
- St. Charles Mercy Hospital
- Toledo Clinic - Oregon
- Firelands Regional Medical Center
- 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
- Toledo Clinic, Incorporated - Main Clinic
- UVMC Cancer Care Center at Upper Valley Medical Center
- Fulton County Health Center
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
- Rapid City Regional Hospital
- Franciscan Skemp Healthcare - La Crosse Campus
Arms of the Study
Arm 1
Experimental
gefitinib
Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease recurrence or unacceptable toxicity. Quality of life is assessed at baseline, 4 weeks, every 12 weeks during study treatment, and then at the end of study treatment. Patients are followed every 3 months for up to 5 years.