Gefitinib in Treating Patients With Locally Advanced Esophageal Cancer
- Registration Number
- NCT00100945
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with locally advanced esophageal cancer.
- Detailed Description
OBJECTIVES:
Primary
* Determine the 1-year overall survival rate in patients with previously treated locally advanced adenocarcinoma of the esophagus or gastroesophageal junction treated with gefitinib as maintenance therapy.
Secondary
* Determine disease-free survival and time to disease recurrence in patients treated with this drug.
* Determine the toxicity of this drug in these patients.
* Determine the quality of life of patients treated with this drug.
OUTLINE: This is a multicenter study.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description gefitinib 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.
- Primary Outcome Measures
Name Time Method 1-year overall survival rate Up to 12 months
- Secondary Outcome Measures
Name Time Method Time to treatment failure Up to 5 years Disease-free survival Up to 5 years Survival time Up to 5 years Quality of life Up to 5 years Time to disease recurrence Up to 5 years
Trial Locations
- Locations (119)
BroMenn Regional Medical Center
🇺🇸Normal, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
St. Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Community Hospital of Ottawa
🇺🇸Ottawa, Illinois, United States
Hickman Cancer Center at Bixby Medical Center
🇺🇸Adrian, Michigan, United States
Community Cancer Center of Monroe
🇺🇸Monroe, Michigan, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Reid Hospital & Health Care Services, Incorporated
🇺🇸Richmond, Indiana, United States
Haematology-Oncology Associates of Ohio and Michigan, PC
🇺🇸Lambertville, Michigan, United States
Lima Memorial Hospital
🇺🇸Lima, Ohio, United States
Fremont Memorial Hospital
🇺🇸Fremont, Ohio, United States
Kenton Oncology, Incorporated
🇺🇸Kenton, Ohio, United States
Toledo Hospital
🇺🇸Toledo, Ohio, United States
Flower Hospital Cancer Center
🇺🇸Sylvania, Ohio, United States
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
Galesburg Clinic
🇺🇸Galesburg, Illinois, United States
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Mercy Medical Center - Sioux City
🇺🇸Sioux City, Iowa, United States
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
Mercy and Unity Cancer Center at Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
🇺🇸Allentown, Pennsylvania, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
HealthEast Cancer Care at St. Joseph's Hospital
🇺🇸St Paul, Minnesota, United States
Park Nicollet Cancer Center
🇺🇸St. Louis Park, Minnesota, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Mercy and Unity Cancer Center at Unity Hospital
🇺🇸Fridley, Minnesota, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸El Dorado, Kansas, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
Regions Hospital Cancer Care Center
🇺🇸St. Paul, Minnesota, United States
MeritCare Broadway
🇺🇸Fargo, North Dakota, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States
MeritCare Bemidji
🇺🇸Bemidji, Minnesota, United States
Fairview Ridges Hospital
🇺🇸Burnsville, Minnesota, United States
United Hospital
🇺🇸St. Paul, Minnesota, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
HealthEast Cancer Care at Woodwinds Health Campus
🇺🇸Woodbury, Minnesota, United States
CCOP - MeritCare Hospital
🇺🇸Fargo, North Dakota, United States
HealthEast Cancer Care at St. John's Hospital
🇺🇸Maplewood, Minnesota, United States
Hutchinson Area Health Care
🇺🇸Hutchinson, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
🇺🇸Robbinsdale, Minnesota, United States
Hennepin County Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Ridgeview Medical Center
🇺🇸Waconia, Minnesota, United States
Mason District Hospital
🇺🇸Havana, Illinois, United States
Hopedale Medical Complex
🇺🇸Hopedale, Illinois, United States
Kewanee Hospital
🇺🇸Kewanee, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
🇺🇸Ottawa, Illinois, United States
Community Cancer Center
🇺🇸Normal, Illinois, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
St. Margaret's Hospital
🇺🇸Spring Valley, Illinois, United States
Cedar Rapids Oncology Associates
🇺🇸Cedar Rapids, Iowa, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
Mercy Memorial Hospital - Monroe
🇺🇸Monroe, Michigan, United States
Meeker County Memorial Hospital
🇺🇸Lichfield, Minnesota, United States
Minnesota Oncology Hematology, PA - Maplewood
🇺🇸Maplewood, Minnesota, United States
Minnesota Oncology Hematology, PA - Woodbury
🇺🇸Woodbury, Minnesota, United States
Blanchard Valley Medical Associates
🇺🇸Findlay, Ohio, United States
Middletown Regional Hospital
🇺🇸Middletown, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic
🇺🇸Toledo, Ohio, United States
Franciscan Skemp Healthcare - La Crosse Campus
🇺🇸La Crosse, Wisconsin, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Graham Hospital
🇺🇸Canton, Illinois, United States
Eureka Community Hospital
🇺🇸Eureka, Illinois, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
🇺🇸Beech Grove, Indiana, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
Siouxland Hematology-Oncology Associates, LLP
🇺🇸Sioux City, Iowa, United States
Wood County Oncology Center
🇺🇸Bowling Green, Ohio, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
Northwest Ohio Oncology Center
🇺🇸Maumee, Ohio, United States
St. Luke's Hospital
🇺🇸Maumee, Ohio, United States
St. Charles Mercy Hospital
🇺🇸Oregon, Ohio, United States
Toledo Clinic - Oregon
🇺🇸Oregon, Ohio, United States
Firelands Regional Medical Center
🇺🇸Sandusky, Ohio, United States
North Coast Cancer Care, Incorporated
🇺🇸Sandusky, Ohio, United States
Mercy Hospital of Tiffin
🇺🇸Tiffin, Ohio, United States
St. Vincent Mercy Medical Center
🇺🇸Toledo, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
Medical University of Ohio Cancer Center
🇺🇸Toledo, Ohio, United States
Fulton County Health Center
🇺🇸Wauseon, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Galesburg Cottage Hospital
🇺🇸Galesburg, Illinois, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
Mercy Capitol Hospital
🇺🇸Des Moines, Iowa, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
🇺🇸Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
🇺🇸Des Moines, Iowa, United States
John Stoddard Cancer Center
🇺🇸Des Moines, Iowa, United States
Associates in Womens Health, PA - North Review
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
Samaritan North Cancer Care Center
🇺🇸Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
🇺🇸Peoria, Illinois, United States
McFarland Clinic, PC
🇺🇸Ames, Iowa, United States
St. Francis Cancer Center at St. Francis Medical Center
🇺🇸Shakopee, Minnesota, United States
Medical Oncology and Hematology Associates - West Des Moines
🇺🇸West Des Moines, Iowa, United States