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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer

Thank you

Trial Information

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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction
meeting the following criteria:

- Newly diagnosed disease

- Tumor is ≥ 20 cm below the incisors

- Tumor extending ≤ 2 cm into cardia

- Tumors must be considered surgically resectable (T1-3)

- No T4 tumors

- Stage T2 N0 M0, T3 N0 M0, T1-3 N+ M0, or T1-3 N0-1 M1a by imaging studies (and biopsy
when appropriate) performed within the past 4 weeks

- M1a disease (i.e., celiac nodal metastasis) is allowed provided other
eligibility criteria are met

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- Granulocytes > 1,000/ mm³

- Platelets > 100,000/mm³

- Creatinine normal or creatinine clearance > 60 mL/min

- Total serum bilirubin < 1.5 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- History of a curatively treated malignancy from which the patient has been
disease-free for ≥ 2 years and has a survival prognosis of > 5 years

- Patients with a history of breast cancer remaining on hormonal treatment > 5 years
are eligible

- No prior severe infusion reaction to a monoclonal antibody

- No infection

- No hypertension

- No uncontrolled diabetes

- No intercurrent illness that would likely interfere with protocol therapy or prevent
surgical resection

- None of the following within the past 6 months:

- New York Heart Association class III-IV congestive heart failure

- Cerebrovascular accident or transient ischemic attack

- Unstable angina or myocardial infarction

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy, radiotherapy, or surgery

- Endoscopy with biopsy and dilation is allowed

- No prior therapy specifically and directly targeting the EGFR pathway

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathological complete response rate

Safety Issue:

No

Principal Investigator

Michael K. Gibson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Federal Government

Study ID:

CDR0000571857

NCT ID:

NCT00551759

Start Date:

June 2008

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • adenocarcinoma of the esophagus
  • stage II esophageal cancer
  • stage III esophageal cancer
  • stage IV esophageal cancer
  • Adenocarcinoma
  • Esophageal Diseases
  • Esophageal Neoplasms

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