Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab 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 stage IIA esophageal cancer, stage IIB esophageal cancer, stage IIIA esophageal cancer, stage IIIB esophageal cancer, stage IIIC esophageal cancer, stage IV esophageal cancer, squamous cell carcinoma of the esophagus
Eligibility Criteria
Inclusion Criteria:
Pathologically (histologic or cytologic) proven diagnosis of primary squamous cell or adenocarcinoma of the esophagus or gastroesophageal junction within 12 weeks prior to registration. Patients with involvement of the gastroesophageal junction with Siewert type I or II tumors (tumors arising from the distal esophagus and involving the esophagogastric junction or tumors starting at the esophagogastric junction and involving the cardia) are eligible.
- 1.1 Disease must be encompassed in a radiotherapy field.
- 1.2 Patients with celiac, perigastric, mediastinal or supraclavicular adenopathy are eligible.
- 1.3 Patients with cervical esophageal carcinoma are eligible.
Stage T1N1M0; T2-4, Any N, M0; Any T, Any N, M1a, based upon the following minimum diagnostic work-up:
- 2.1 History/physical examination within 6 weeks prior to registration
- 2.2 Positron emission tomography (PET)/positron emission tomography-computed tomography (PET-CT) scan (strongly recommended) or chest/abdominal CT within 6 weeks prior to registration
- 2.3 Electrocardiogram (EKG) within 6 weeks of study entry
- 2.4 Endoscopy with biopsy or cytology by fine needle aspiration (FNA) (must be able to document histologic subtype) within 12 weeks of study entry. Patients with T3-4 proximal thoracic esophageal tumors (15-25 cm) must undergo bronchoscopy to exclude fistula. (NOTE: Any images from endoscopic procedures up to the time of progression must be kept in the patient's confidential study file.)
- Zubrod performance status 0-2
- Age ≥ 18 and ≤ 74 (upper limit was set at 74 in an amendment)
Complete blood count (CBC)/differential obtained within 2 weeks prior to registration on study, with adequate bone marrow function defined as follows:
- 5.1 Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
- 5.2 Platelets ≥ 100,000 cells/mm3
- 5.3 Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥8.0 g/dl is acceptable.)
Additional laboratory studies obtained within 2 weeks prior to registration on study
- 6.1 Creatinine ≤ 1.5 mg/dl
- 6.2 Bilirubin ≤ 1.5 x upper limit of normal
- 6.3 Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 x upper limit of normal
- 6.4 Serum pregnancy test for women of childbearing potential
- Patient's total intake (oral/enteral) must be ≥ 1500 kCal/day
- Patient must provide study-specific informed consent prior to study entry
- Women of childbearing potential and male participants must practice adequate contraception
Exclusion Criteria:
- Evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi. Patients with T3-4 proximal thoracic esophageal tumors (15-25 cm) must undergo bronchoscopy to exclude fistula.
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
- Prior systemic chemotherapy for esophageal cancer; note that prior chemotherapy for a different cancer is allowable.
- Prior radiation therapy that would result in overlap of planned radiation therapy fields.
- Prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR) pathway.
- Prior platinum-based and/or paclitaxel-based therapy.
- Prior allergic reaction to the study drugs involved in this protocol.
- Prior severe infusion reaction to a monoclonal antibody.
Severe, active comorbidity, defined as follows:
- 9.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months
- 9.2 Transmural myocardial infarction within the last 6 months
- 9.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- 9.4 Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- 9.5 Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised patients.
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
- Women who are nursing.
Sites / Locations
- Arizona Oncology - Tucson
- Auburn Radiation Oncology
- Radiation Oncology Centers - Cameron Park
- Mercy Cancer Center at Mercy San Juan Medical Center
- Enloe Cancer Center at Enloe Medical Center
- California Cancer Center - Woodward Park Office
- Saint Agnes Cancer Center at Saint Agnes Medical Center
- Memorial Medical Center
- Radiation Oncology Center - Roseville
- Radiological Associates of Sacramento Medical Group, Incorporated
- University of California Davis Cancer Center
- Mercy General Hospital
- Solano Radiation Oncology Center
- Sutter Solano Medical Center
- Rocky Mountain Cancer Centers - Aurora
- Porter Adventist Hospital
- George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
- William W. Backus Hospital
- CCOP - Christiana Care Health Services
- University of Florida Shands Cancer Center
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
- Center for Cancer Care and Research at Watson Clinic, LLP
- CCOP - Mount Sinai Medical Center
- Baptist-South Miami Regional Cancer Program
- M.D. Anderson Cancer Center at Orlando
- John B. Amos Cancer Center
- Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
- Cancer Research Center of Hawaii
- Queen's Cancer Institute at Queen's Medical Center
- Hawaii Medical Center - East
- Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- University of Chicago Cancer Research Center
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Advocate Lutheran General Cancer Care Center
- Swedish-American Regional Cancer Center
- Cancer Institute at St. John's Hospital
- Saint John's Cancer Center at Saint John's Medical Center
- Bloomington Hospital Regional Cancer Institute
- Radiation Oncology Associates Southwest
- Parkview Regional Cancer Center at Parkview Health
- Methodist Cancer Center at Methodist Hospital
- Central Indiana Cancer Centers - East
- Cancer Center at Ball Memorial Hospital
- Memorial Hospital of South Bend
- McFarland Clinic, PC
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- Mercy Cancer Center at Mercy Medical Center - North Iowa
- Siouxland Hematology-Oncology Associates, LLP
- James Graham Brown Cancer Center at University of Louisville
- Mary Bird Perkins Cancer Center - Baton Rouge
- Greenebaum Cancer Center at University of Maryland Medical Center
- Greater Baltimore Medical Center Cancer Center
- St. Agnes Hospital Cancer Center
- Hudner Oncology Center at Saint Anne's Hospital - Fall River
- Saint Joseph Mercy Cancer Center
- Josephine Ford Cancer Center at Henry Ford Hospital
- Genesys Hurley Cancer Institute
- Lacks Cancer Center at Saint Mary's Health Care
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- West Michigan Cancer Center
- St. Mary Mercy Hospital
- Mercy Regional Cancer Center at Mercy Hospital
- Seton Cancer Institute at Saint Mary's - Saginaw
- MeritCare Bemidji
- Mercy and Unity Cancer Center at Mercy Hospital
- Minnesota Oncology - Maplewood
- Regions Hospital Cancer Care Center
- United Hospital
- University of Mississippi Cancer Clinic
- Cancer Institute of Cape Girardeau, LLC
- Saint Louis University Cancer Center
- Missouri Baptist Cancer Center
- David C. Pratt Cancer Center at St. John's Mercy
- Billings Clinic - Downtown
- Sletten Cancer Institute at Benefis Healthcare
- Methodist Estabrook Cancer Center
- Lakeside Hospital
- CCOP - Nevada Cancer Research Foundation
- Payson Center for Cancer Care at Concord Hospital
- Seacoast Cancer Center at Wentworth - Douglass Hospital
- Center for Cancer Care at Exeter Hospital
- Kingsbury Center for Cancer Care at Cheshire Medical Center
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- Elliot Regional Cancer Center at Elliot Hospital
- Monmouth Medical Center
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
- Frederick R. and Betty M. Smith Cancer Treatment Center
- J. Phillip Citta Regional Cancer Center at Community Medical Center
- Cancer Institute of New Jersey at Cooper - Voorhees
- New York Oncology Hematology, PC at Albany Regional Cancer Care
- Lourdes Regional Cancer Center
- Charles R. Wood Cancer Center at Glens Falls Hospital
- Beth Israel Medical Center - Petrie Division
- St. Luke's - Roosevelt Hospital Center - St.Luke's Division
- Memorial Sloan-Kettering Cancer Center
- Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
- Mission Hospitals - Memorial Campus
- Alamance Cancer Center at Alamance Regional Medical Center
- Presbyterian Cancer Center at Presbyterian Hospital
- Kinston Medical Specialists
- CCOP - MeritCare Hospital
- McDowell Cancer Center at Akron General Medical Center
- Summa Center for Cancer Care at Akron City Hospital
- Barberton Citizens Hospital
- Mercy Cancer Center at Mercy Medical Center
- Aultman Cancer Center at Aultman Hospital
- Case Comprehensive Cancer Center
- MetroHealth Cancer Care Center at MetroHealth Medical Center
- Lake/University Ireland Cancer Center
- Southwest General Health Center
- UHHS Chagrin Highlands Medical Center
- Robinson Radiation Oncology
- UHHS Westlake Medical Center
- Oklahoma University Cancer Institute
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Clackamas Radiation Oncology Center
- Willamette Valley Cancer Center - Eugene
- Providence Cancer Center at Providence Portland Medical Center
- Providence St. Vincent Medical Center
- UPMC Cancer Center at Beaver Medical Center
- UPMC Cancer Center at Jefferson Regional Medical Center
- Delaware County Regional Cancer Center at Delaware County Memorial Hospital
- Regional Cancer Center - Erie
- Adams Cancer Center
- UPMC Cancer Center - Arnold Palmer Pavilion
- Frankford Hospital Cancer Center - Torresdale Campus
- Albert Einstein Cancer Center
- UPMC - Shadyside
- UPMC Cancer Center at UPMC St. Margaret
- UPMC Cancer Center at UPMC Passavant
- McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
- UPMC Cancer Center at UPMC Northwest
- York Cancer Center at Apple Hill Medical Center
- Rhode Island Hospital Comprehensive Cancer Center
- Northmain Radiation Oncology
- Hollings Cancer Center at Medical University of South Carolina
- Cancer Centers of the Carolinas - Faris Road
- CCOP - Greenville
- Cancer Centers of the Carolinas - Seneca
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Cancer Centers of the Carolinas - Spartanburg
- Rapid City Regional Hospital
- Sanford Cancer Center at Sanford USD Medical Center
- Thompson Cancer Survival Center
- Harrington Cancer Center
- Texas Oncology, PA at Harris Center HEB
- Texas Oncology, PA at Texas Cancer Center - Denton South
- Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
- Memorial Hermann Hospital - Memorial City
- Longview Cancer Center
- Joe Arrington Cancer Research and Treatment Center
- Cancer Care Centers of South Texas - Northeast
- Texas Oncology, PA at Texas Cancer Center - Sherman
- Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
- Tyler Cancer Center
- Texas Oncology, PA - Wichita Falls
- Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
- Dixie Regional Medical Center - East Campus
- Utah Cancer Specialists at UCS Cancer Center
- Huntsman Cancer Institute at University of Utah
- Northwest Cancer Specialists at Vancouver Cancer Center
- Schiffler Cancer Center at Wheeling Hospital
- St. Mary's Hospital Medical Center - Green Bay
- St. Vincent Hospital Regional Cancer Center
- Bay Area Cancer Care Center at Bay Area Medical Center
- Veterans Affairs Medical Center - Milwaukee
- Regional Cancer Center at Oconomowoc Memorial Hospital
- Door County Cancer Center at Door County Memorial Hospital
- Waukesha Memorial Hospital Regional Cancer Center
- University of Wisconcin Cancer Center at Aspirus Wausau Hospital
- Saint John Regional Hospital
- McGill Cancer Centre at McGill University
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Chemoradiation + Cetuximab
Chemoradiation
External beam radiation therapy (RT) with concurrent weekly paclitaxel, cisplatin, and cetuximab
External beam radiation therapy with concurrent weekly paclitaxel, and cisplatin