A Phase 2 Randomized Study to Measure Response Rate and Toxicity of Oxaliplatin/5-FU Plus Cetuximab Followed by Post-Operative Docetaxel and Cetuximab in Patients With Operable Adenocarcinoma of the Esophagus
OBJECTIVES:
Primary
- To determine the pathologic complete response rate in patients with resectable
adenocarcinoma of the esophagus or gastroesophageal junction treated with neoadjuvant
chemoradiotherapy comprising oxaliplatin, fluorouracil, and radiation therapy combined
with cetuximab.
Secondary
- To evaluate the safety of this regimen in these patients.
- To evaluate the safety and tolerability of adjuvant therapy comprising cetuximab and
docetaxel in these patients.
OUTLINE: This is a multicenter study.
- Neoadjuvant chemoradiotherapy and cetuximab: Patients receive oxaliplatin IV over 2
hours on days 1, 15, and 29, cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29,
and fluorouracil IV continuously over 24 hours on days 1-35. Patients also undergo
radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients then
proceed to surgery.
- Surgery: Patients undergo surgical resection within 4-8 weeks after completion of
neoadjuvant chemoradiotherapy and cetuximab. Patients with an R0 or R1 resection
proceed to adjuvant therapy. Patients whose tumors have not been completely resected or
who have metastatic disease discontinue protocol therapy and receive further therapy at
the discretion of the treating physician.
- Adjuvant therapy: Within 4-8 weeks after surgery, patients receive docetaxel IV over 1
hour on days 1, 8, 15, 22, and 29 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22,
29, and 36. Treatment repeats every 6 weeks for 2 courses in the absence of disease
progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, and then every 6 months for 3-5 years.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Pathological complete response rate
No
Michael K. Gibson, MD
Study Chair
University of Pittsburgh
United States: Federal Government
CDR0000571857
NCT00551759
June 2008
Name | Location |
---|---|
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
Joliet Oncology-Hematology Associates, Limited - West | Joliet, Illinois 60435 |
Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
Cedar Rapids Oncology Associates | Cedar Rapids, Iowa 52403 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Minnesota Oncology Hematology, PA - Maplewood | Maplewood, Minnesota 55109 |
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale, Minnesota 55422-2900 |
St. Francis Cancer Center at St. Francis Medical Center | Shakopee, Minnesota 55379 |
Park Nicollet Cancer Center | St. Louis Park, Minnesota 55416 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Minnesota Oncology Hematology, PA - Woodbury | Woodbury, Minnesota 55125 |
Aultman Cancer Center at Aultman Hospital | Canton, Ohio 44710-1799 |
Mercy Cancer Center at Mercy Medical Center | Canton, Ohio 44708 |
Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
Medical X-Ray Center, PC | Sioux Falls, South Dakota 57105 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
Marshfield Clinic - Indianhead Center | Rice Lake, Wisconsin 54868 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
Wesley Medical Center | Wichita, Kansas 67214 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Overlook Hospital | Summit, New Jersey 07902-0220 |
Carol G. Simon Cancer Center at Morristown Memorial Hospital | Morristown, New Jersey 07962 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
McCreery Cancer Center at Ottumwa Regional | Ottumwa, Iowa 52501 |
Our Lady of Mercy Medical Center Comprehensive Cancer Center | Bronx, New York 10466 |
Southwest Medical Center | Liberal, Kansas 67901 |
Swedish-American Regional Cancer Center | Rockford, Illinois 61104-2315 |
Gundersen Lutheran Center for Cancer and Blood | La Crosse, Wisconsin 54601 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton, New Jersey 08053 |
Fox Chase Virtua Health Cancer Program at Virtua West Jersey | Voorhees, New Jersey 08043 |
Hematology Oncology Associates - Skokie | Skokie, Illinois 60076 |
UPMC Cancer Centers | Pittsburgh, Pennsylvania 15232 |
Hematology and Oncology Associates | Chicago, Illinois 60611 |
Midwest Center for Hematology/Oncology | Joliet, Illinois 60432 |
North Shore Oncology and Hematology Associates, Limited - Libertyville | Libertyville, Illinois 60048 |
John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Mercy Capitol Hospital | Des Moines, Iowa 50307 |
Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Immanuel Medical Center | Omaha, Nebraska 68122 |
Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Pottstown Memorial Regional Cancer Center | Pottstown, Pennsylvania 19464 |
Mercy Cancer Center at Mercy Medical Center - North Iowa | Mason City, Iowa 50401 |
Cancer Resource Center - Lincoln | Lincoln, Nebraska 68510 |
Tunnell Cancer Center at Beebe Medical Center | Lewes, Delaware 19958 |
La Grange Oncology Associates - Geneva | Naperville, Illinois 60563 |
Cancer Care and Hematology Specialists of Chicagoland - Niles | Niles, Illinois 60714 |
McFarland Clinic, PC | Ames, Iowa 50010 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
Union Hospital Cancer Program at Union Hospital | Elkton MD, Maryland 21921 |
Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
St. Luke's Cancer Network at St. Luke's Hospital | Bethlehem, Pennsylvania 18015 |
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
Hematology and Oncology Associates of Northeastern Pennsylvania | Scranton, Pennsylvania 18510 |
Center for Cancer Treatment & Prevention at Sacred Heart Hospital | Eau Claire, Wisconsin 54701 |
Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire, Wisconsin 54701 |
Saint Joseph's Hospital | Marshfield, Wisconsin 54449 |
Marshfield Clinic - Lakeland Center | Minocqua, Wisconsin 54548 |
Ministry Medical Group at Saint Mary's Hospital | Rhinelander, Wisconsin 54501 |
Saint Michael's Hospital Cancer Center | Stevens Point, Wisconsin 54481 |
Marshfield Clinic - Wausau Center | Wausau, Wisconsin 54401 |
Marshfield Clinic - Weston Center | Weston, Wisconsin 54476 |
Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids, Wisconsin 54494 |
Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
Cancer Center of Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
CCOP - Main Line Health | Wynnewood, Pennsylvania 19096 |