Capecitabine With or Without Sunitinib Malate as First-Line Therapy in Treating Patients With Metastatic Cancer of the Esophagus or Gastroesophageal Junction
- Conditions
- Esophageal CancerAdenocarcinoma of the Gastroesophageal Junction
- Interventions
- Registration Number
- NCT00891878
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether capecitabine is more effective when given alone or together with sunitinib malate in treating patients with metastatic esophageal cancer or gastroesophageal junction cancer.
PURPOSE: This randomized phase II trial is studying how well capecitabine works compared with capecitabine given together with sunitinib malate as first-line therapy in treating patients with metastatic cancer of the esophagus or gastroesophageal junction.
- Detailed Description
OBJECTIVES:
Primary
* Compare the progression-free survival of elderly (age ≥ 65 years) and/or poor performance status patients with metastatic adenocarcinoma of the esophagus or gastroesophageal junction treated with capecitabine with verus without sunitinib malate.
* Report other indicators of efficacy with these regimens, including the confirmed response rate, overall survival, time to tumor progression, duration of response, and time to treatment failure.
* Compare the adverse event profiles of these regimens in these patients.
Secondary
* Explore whether certain key proteins associated with anti-VEGF therapy are able to predict tumor response.
* Bank paraffin-embedded tissue blocks or slides, and blood products for future studies.
OUTLINE: This is a multicenter study. Patients are stratified according to gender (male vs female), ECOG performance status (0 vs 1 vs 2), and age (≥ 65 years vs \< 65 years). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm II at the physician's discretion.
* Arm II: Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Tumor tissue samples are collected at baseline for evaluation of protein markers as possible predictors of tumor response to this regimen. Samples are analyzed by IHC for expression levels of markers
After completion of study therapy, patients are followed periodically for 3 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I capecitabine Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm II at the physician's discretion. Arm II capecitabine Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21. Arm II sunitinib malate Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
- Primary Outcome Measures
Name Time Method Comparison of Progression-free Survival Up to 3 years The primary analysis will be a comparison of Arm A to Arm B using a one-sided log-rank test between the 2 Kaplan-Meier curves. All patients meeting the eligibility criteria, who started treatment will be considered evaluable for the primary endpoint. If a patient is still alive 3 years after registration, no further follow-up is required. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
- Secondary Outcome Measures
Name Time Method Time to Treatment Failure Up to 3 years Time to treatment failure is defined to be the time from the date of randomization to the date at which the patient is removed from treatment due to progression, adverse events, or refusal.
Response Rate (Complete Response or Partial Response) Up to 3 years A confirmed tumor response is defined to be a CR or PR noted as the objective status on 2 consecutive evaluations ≥4 weeks apart. Confirmed tumor response will be evaluated using the first 6 cycles of treatment. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response. The confirmed response rates between the 2 arms will be compared using a Chi-Square or Fisher's Exact test. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Time to Disease Progression Up to 3 years Time to disease progression is defined as the time from randomization to the earliest date documentation of disease progression occurs. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. The distribution of time-to-progression will be estimated using the method of Kaplan-Meier.
Overall Survival Up to 3 years Overall survival is defined as the time from randomization to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier.
Duration of Response Up to 3 years Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented.
Trial Locations
- Locations (181)
Memorial Hospital
🇺🇸Carthage, Illinois, United States
Graham Hospital
🇺🇸Canton, Illinois, United States
Illinois CancerCare - Havana
🇺🇸Havana, Illinois, United States
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
St. James Healthcare Cancer Care
🇺🇸Butte, Montana, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
AnMed Cancer Center
🇺🇸Anderson, South Carolina, United States
Geisinger Medical Group - Scenery Park
🇺🇸State College, Pennsylvania, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Northern Montana Hospital
🇺🇸Havre, Montana, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Illinois CancerCare - Carthage
🇺🇸Carthage, Illinois, United States
Eureka Community Hospital
🇺🇸Eureka, Illinois, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
Illinois CancerCare - Kewanee Clinic
🇺🇸Kewanee, Illinois, United States
Illinois CancerCare - Galesburg
🇺🇸Galesburg, Illinois, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
OSF Holy Family Medical Center
🇺🇸Monmouth, Illinois, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
🇺🇸Hartford, Connecticut, United States
St. Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Illinois CancerCare - Eureka
🇺🇸Eureka, Illinois, United States
Mason District Hospital
🇺🇸Havana, Illinois, United States
Illinois CancerCare - Canton
🇺🇸Canton, Illinois, United States
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
St. Joseph Mercy Oakland
🇺🇸Pontiac, Michigan, United States
Community Cancer Center
🇺🇸Elyria, Ohio, United States
Arch Medical Services, Incorporated at Center for Cancer Care and Research
🇺🇸Saint Louis, Missouri, United States
Illinois CancerCare - Princeton
🇺🇸Princeton, Illinois, United States
St. John Macomb Hospital
🇺🇸Warren, Michigan, United States
Illinois CancerCare - Pekin
🇺🇸Pekin, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
🇺🇸Ottawa, Illinois, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
Hickman Cancer Center at Bixby Medical Center
🇺🇸Adrian, Michigan, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
🇺🇸Beech Grove, Indiana, United States
Miller - Dwan Medical Center
🇺🇸Duluth, Minnesota, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
🇺🇸Dearborn, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
St. Mary Mercy Hospital
🇺🇸Livonia, Michigan, United States
Bozeman Deaconess Cancer Center
🇺🇸Bozeman, Montana, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
Community Cancer Center of Monroe
🇺🇸Monroe, Michigan, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
Blanchard Valley Medical Associates
🇺🇸Findlay, Ohio, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Missouri Baptist Cancer Center
🇺🇸Saint Louis, Missouri, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
St. Alexius Medical Center Cancer Center
🇺🇸Bismarck, North Dakota, United States
Wayne Hospital
🇺🇸Greenville, Ohio, United States
St. Vincent Mercy Medical Center
🇺🇸Toledo, Ohio, United States
Samaritan North Cancer Care Center
🇺🇸Dayton, Ohio, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
Ridgeview Medical Center
🇺🇸Waconia, Minnesota, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
Bismarck Cancer Center
🇺🇸Bismarck, North Dakota, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Geisinger Hazleton Cancer Center
🇺🇸Hazleton, Pennsylvania, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
North Coast Cancer Care - Clyde
🇺🇸Clyde, Ohio, United States
Rutherford Hospital
🇺🇸Rutherfordton, North Carolina, United States
Kalispell Medical Oncology at KRMC
🇺🇸Kalispell, Montana, United States
Middletown Regional Hospital
🇺🇸Franklin, Ohio, United States
Northwest Ohio Oncology Center
🇺🇸Maumee, Ohio, United States
Medcenter One Hospital Cancer Care Center
🇺🇸Bismarck, North Dakota, United States
Altru Cancer Center at Altru Hospital
🇺🇸Grand Forks, North Dakota, United States
St. Luke's Hospital
🇺🇸Maumee, Ohio, United States
Wood County Oncology Center
🇺🇸Bowling Green, Ohio, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Hennepin County Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸El Dorado, Kansas, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Cancer Center of Kansas-Independence
🇺🇸Independence, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
Rocky Mountain Oncology
🇺🇸Casper, Wyoming, United States
Sanford Cancer Center at Sanford USD Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Fredericksburg Oncology, Incorporated
🇺🇸Fredericksburg, Virginia, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸Sheridan, Wyoming, United States
Duluth Clinic Cancer Center - Duluth
🇺🇸Duluth, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital
🇺🇸Fridley, Minnesota, United States
Hutchinson Area Health Care
🇺🇸Hutchinson, Minnesota, United States
Minnesota Oncology Hematology, PA - Maplewood
🇺🇸Maplewood, Minnesota, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Regions Hospital Cancer Care Center
🇺🇸Saint Paul, Minnesota, United States
United Hospital
🇺🇸Saint Paul, Minnesota, United States
Willmar Cancer Center at Rice Memorial Hospital
🇺🇸Willmar, Minnesota, United States
Illinois CancerCare - Bloomington
🇺🇸Bloomington, Illinois, United States
Galesburg Clinic, PC
🇺🇸Galesburg, Illinois, United States
Illinois CancerCare - Monmouth
🇺🇸Monmouth, Illinois, United States
Community Hospital of Ottawa
🇺🇸Ottawa, Illinois, United States
Illinois CancerCare - Community Cancer Center
🇺🇸Normal, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Mercy Medical Center - Sioux City
🇺🇸Sioux City, Iowa, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
Cancer Center of Kansas - Fort Scott
🇺🇸Fort Scott, Kansas, United States
Lawrence Memorial Hospital
🇺🇸Lawrence, Kansas, United States
Cancer Center of Kansas, PA - Liberal
🇺🇸Liberal, Kansas, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
Haematology-Oncology Associates of Ohio and Michigan, PC
🇺🇸Lambertville, Michigan, United States
HealthEast Cancer Care at St. John's Hospital
🇺🇸Maplewood, Minnesota, United States
St. Francis Cancer Center at St. Francis Medical Center
🇺🇸Shakopee, Minnesota, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
Minnesota Oncology Hematology, PA - Woodbury
🇺🇸Woodbury, Minnesota, United States
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
Sletten Cancer Institute at Benefis Healthcare
🇺🇸Great Falls, Montana, United States
Cancer Resource Center - Lincoln
🇺🇸Lincoln, Nebraska, United States
Mid Dakota Clinic, PC
🇺🇸Bismarck, North Dakota, United States
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
Hematology Oncology Center
🇺🇸Elyria, Ohio, United States
Lima Memorial Hospital
🇺🇸Lima, Ohio, United States
St. Charles Mercy Hospital
🇺🇸Oregon, Ohio, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
St. Anne Mercy Hospital
🇺🇸Toledo, Ohio, United States
Geisinger Cancer Institute at Geisinger Health
🇺🇸Danville, Pennsylvania, United States
Clinton Memorial Hospital
🇺🇸Wilmington, Ohio, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
Medical X-Ray Center, PC
🇺🇸Sioux Falls, South Dakota, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Mercy Memorial Hospital - Monroe
🇺🇸Monroe, Michigan, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
Toledo Clinic - Oregon
🇺🇸Oregon, Ohio, United States
North Coast Cancer Care, Incorporated
🇺🇸Sandusky, Ohio, United States
Flower Hospital Cancer Center
🇺🇸Sylvania, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic
🇺🇸Toledo, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
Fulton County Health Center
🇺🇸Wauseon, Ohio, United States
Saint Joseph Mercy Cancer Center
🇺🇸Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Immanuel Medical Center
🇺🇸Omaha, Nebraska, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center
🇺🇸Omaha, Nebraska, United States
Creighton University Medical Center
🇺🇸Omaha, Nebraska, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
Mercy Regional Cancer Center at Mercy Medical Center
🇺🇸Cedar Rapids, Iowa, United States
Illinois CancerCare - Macomb
🇺🇸Macomb, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
🇺🇸Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
BroMenn Regional Medical Center
🇺🇸Normal, Illinois, United States
Illinois CancerCare - Peru
🇺🇸Peru, Illinois, United States
Perry Memorial Hospital
🇺🇸Princeton, Illinois, United States
Illinois CancerCare - Spring Valley
🇺🇸Spring Valley, Illinois, United States
Medical Oncology and Hematology Associates - West Des Moines
🇺🇸Clive, Iowa, United States
Reid Hospital & Health Care Services
🇺🇸Richmond, Indiana, United States
Cedar Rapids Oncology Associates
🇺🇸Cedar Rapids, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP
🇺🇸Sioux City, Iowa, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
🇺🇸Robbinsdale, Minnesota, United States
Park Nicollet Cancer Center
🇺🇸Saint Louis Park, Minnesota, United States
Foote Memorial Hospital
🇺🇸Jackson, Michigan, United States
Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital
🇺🇸Port Huron, Michigan, United States
Fairview Ridges Hospital
🇺🇸Burnsville, Minnesota, United States
Seton Cancer Institute at Saint Mary's - Saginaw
🇺🇸Saginaw, Michigan, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
🇺🇸Wilkes-Barre, Pennsylvania, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Fisher-Titus Medical Center
🇺🇸Norwalk, Ohio, United States
Medical University of Ohio Cancer Center
🇺🇸Toledo, Ohio, United States
Mercy Hospital of Tiffin
🇺🇸Tiffin, Ohio, United States
Toledo Hospital
🇺🇸Toledo, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, 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 at Iowa Lutheran Hospital
🇺🇸Des Moines, Iowa, United States