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A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery


Phase 3
18 Years
74 Years
Open (Enrolling)
Both
Esophageal Cancer

Thank you

Trial Information

A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery


OBJECTIVES:

Primary

- To evaluate whether the addition of cetuximab to chemotherapy comprising paclitaxel,
cisplatin, and radiotherapy improves overall survival compared with paclitaxel,
cisplatin, and radiotherapy alone in patients with esophageal cancer treated without
surgery.

Secondary

- To evaluate whether the addition of cetuximab to paclitaxel, cisplatin, and
radiotherapy improves local control by increasing the clinical complete response and
decreasing local recurrence in these patients.

- To evaluate adverse events in these patients.

- To evaluate endoscopic complete response rates in these patients.

- To evaluate if the addition of cetuximab to paclitaxel, cisplatin, and radiotherapy
improves the Esophageal Cancer Subscale score of the FACT-E quality of life tool.

- To evaluate the quality-adjusted survival of each treatment arm using EQ-5D if the
primary endpoint supports the primary hypothesis.

OUTLINE: This is a multicenter study. Patients are stratified according to histology
(adenocarcinoma* vs squamous), cancer lesion size (< 5 cm vs ≥ 5 cm), and disease status of
celiac nodes (present vs absent). Patients are randomized to 1 of 2 treatment arms.

NOTE: * The adenocarcinoma stratum is closed as of 5/3/2012.

- Arm I: Patients receive cetuximab IV over 1-2 hours, paclitaxel IV over 1 hour, and
cisplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36. Patients also undergo
radiotherapy once daily, 5 days a week, for 5½ weeks for a total dose of 50.4Gy.

- Arm II: Patients receive paclitaxel and cisplatin as in arm I. Patients also undergo
radiotherapy as in arm I.

Patients undergo endoscopy 6 to 8 weeks after completion of chemoradiotherapy. Quality of
life is assessed at baseline, within 1 week of post-treatment endoscopy, and at 1 and 2
years from beginning of study treatment.

After completion of study treatment, patients are followed periodically.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed primary squamous cell or adenocarcinoma* of the esophagus or
gastroesophageal junction

- 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

- Patients with cervical esophageal carcinoma are eligible

- Patients with celiac, perigastric, mediastinal, or supraclavicular adenopathy
are eligible NOTE: * The adenocarcinoma stratum is closed as of 5/3/2012.

- Stage T1, N1, M0; T2-4, Any N, M0; or Any T, Any N, M1a disease based on
history/physical examination, endoscopy with biopsy, AND PET/PET-CT scan or
chest/abdominal CT scan within 6 weeks prior to registration

- Disease must be encompassed in a radiotherapy field

- No evidence of tracheoesophageal fistulas 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

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-2

- ANC ≥ 1,500/mm³

- Platelets ≥ 100,000 cells/mm³

- Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL
allowed)

- Creatinine ≤ 1.5 mg/dL

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST or ALT ≤ 3 times ULN

- Negative pregnancy test

- Not pregnant or nursing

- Fertile patients must use effective contraception

- Total intake (oral/enteral) must be ≥ 1,500 kCal/day

- No prior invasive malignancy except nonmelanomatous skin cancer (e.g., carcinoma in
situ of the breast, oral cavity, or cervix) unless disease-free for ≥ 2 years

- No prior allergic reaction to the study drugs

- No prior severe infusion reaction to a monoclonal antibody

- No severe, active comorbidity, including any of the following:

- Unstable angina and/or congestive heart failure requiring hospitalization within
the past 3 months

- Transmural myocardial infarction within the past 6 months

- Acute bacterial or fungal infection requiring intravenous antibiotics

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy

- Acquired immune deficiency syndrome based upon current CDC definition

- HIV testing is not required for entry into this study

PRIOR CONCURRENT THERAPY:

- No prior systemic chemotherapy for esophageal cancer (prior chemotherapy for another
cancer allowed)

- No prior therapy that specifically and directly targets the EGFR pathway

- No prior platinum-based and/or paclitaxel-based therapy

- No prior radiotherapy that would result in overlap of planned study radiotherapy
fields

- No concurrent investigational agent

- No concurrent cytotoxic agent

- No other concurrent radiotherapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Overall survival (failure: death due to any cause)

Safety Issue:

No

Principal Investigator

Mohan Suntharalingam, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Maryland Greenebaum Cancer Center

Authority:

Unspecified

Study ID:

CDR0000538085

NCT ID:

NCT00655876

Start Date:

June 2008

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • 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
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021
Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
University of Chicago Cancer Research Center Chicago, Illinois  60637
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
Porter Adventist Hospital Denver, Colorado  80210
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus New Britain, Connecticut  06050
Methodist Cancer Center at Methodist Hospital Indianapolis, Indiana  46202
Siouxland Hematology-Oncology Associates, LLP Sioux City, Iowa  51101
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
MeritCare Bemidji Bemidji, Minnesota  56601
Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
Regions Hospital Cancer Care Center St. Paul, Minnesota  55101
United Hospital St. Paul, Minnesota  55102
CCOP - MeritCare Hospital Fargo, North Dakota  58122
Aultman Cancer Center at Aultman Hospital Canton, Ohio  44710-1799
Mercy Cancer Center at Mercy Medical Center Canton, Ohio  44708
Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
MetroHealth Cancer Care Center at MetroHealth Medical Center Cleveland, Ohio  44109
Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa, Oklahoma  74136
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls, South Dakota  57117-5039
Rapid City Regional Hospital Rapid City, South Dakota  57709
Memorial Hospital of South Bend South Bend, Indiana  46601
Albert Einstein Cancer Center Philadelphia, Pennsylvania  19141
CCOP - Greenville Greenville, South Carolina  29615
Harrington Cancer Center Amarillo, Texas  79106
Joe Arrington Cancer Research and Treatment Center Lubbock, Texas  79410-1894
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756-0002
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
Monmouth Medical Center Long Branch, New Jersey  07740-6395
University of California Davis Cancer Center Sacramento, California  95817
John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines, Iowa  50309
Josephine Ford Cancer Center at Henry Ford Hospital Detroit, Michigan  48202
Thompson Cancer Survival Center Knoxville, Tennessee  37916
James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky  40202
McDowell Cancer Center at Akron General Medical Center Akron, Ohio  44307
Lake/University Ireland Cancer Center Mentor, Ohio  44060
Waukesha Memorial Hospital Regional Cancer Center Waukesha, Wisconsin  53188
University of Florida Shands Cancer Center Gainesville, Florida  32610-0232
Baptist-South Miami Regional Cancer Program Miami, Florida  33176
Mission Hospitals - Memorial Campus Asheville, North Carolina  28801
Presbyterian Cancer Center at Presbyterian Hospital Charlotte, North Carolina  28233-3549
Rhode Island Hospital Comprehensive Cancer Center Providence, Rhode Island  02903
Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54307-3508
St. Mary's Hospital Medical Center - Green Bay Green Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical Center Marinette, Wisconsin  54143
Lourdes Regional Cancer Center Binghamton, New York  13905
David C. Pratt Cancer Center at St. John's Mercy St. Louis, Missouri  63141
Utah Cancer Specialists at UCS Cancer Center Salt Lake City, Utah  84106
Greenebaum Cancer Center at University of Maryland Medical Center Baltimore, Maryland  21201
M.D. Anderson Cancer Center at Orlando Orlando, Florida  32806
Advocate Lutheran General Cancer Care Center Park Ridge, Illinois  60068-1174
Swedish-American Regional Cancer Center Rockford, Illinois  61104-2315
University of Mississippi Cancer Clinic Jackson, Mississippi  39216-4505
CCOP - Nevada Cancer Research Foundation Las Vegas, Nevada  89109-2306
Beth Israel Medical Center - Petrie Division New York, New York  10003-3803
St. Luke's - Roosevelt Hospital Center - St.Luke's Division New York, New York  10027
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
Methodist Estabrook Cancer Center Omaha, Nebraska  68114-4199
Huntsman Cancer Institute at University of Utah Salt Lake City, Utah  84112
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton Marlton, New Jersey  08053
Sutter Solano Medical Center Vallejo, California  94589
Ella Milbank Foshay Cancer Center at Jupiter Medical Center Jupiter, Florida  33458
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Boise, Idaho  83706
Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines, Iowa  50314
Mary Bird Perkins Cancer Center - Baton Rouge Baton Rouge, Louisiana  70809
Kingsbury Center for Cancer Care at Cheshire Medical Center Keene, New Hampshire  03431
Cancer Institute of New Jersey at Cooper - Voorhees Voorhees, New Jersey  08043
Charles R. Wood Cancer Center at Glens Falls Hospital Glens Falls, New York  12801
Providence Cancer Center at Providence Portland Medical Center Portland, Oregon  97213-2967
Providence St. Vincent Medical Center Portland, Oregon  97225
Delaware County Regional Cancer Center at Delaware County Memorial Hospital Drexel Hill, Pennsylvania  19026
Dixie Regional Medical Center - East Campus Saint George, Utah  84770
William W. Backus Hospital Norwich, Connecticut  06360
California Cancer Center - Woodward Park Office Fresno, California  93720
Cancer Center at Ball Memorial Hospital Muncie, Indiana  47303
Mercy Cancer Center at Mercy Medical Center - North Iowa Mason City, Iowa  50401
Missouri Baptist Cancer Center St. Louis, Missouri  63131
John B. Amos Cancer Center Columbus, Georgia  31904
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler Savannah, Georgia  31405
McFarland Clinic, PC Ames, Iowa  50010
Greater Baltimore Medical Center Cancer Center Baltimore, Maryland  21204
St. Mary Mercy Hospital Livonia, Michigan  48154
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Billings Clinic - Downtown Billings, Montana  59107-7000
Sletten Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
Frederick R. and Betty M. Smith Cancer Treatment Center Sparta, New Jersey  07871
Summa Center for Cancer Care at Akron City Hospital Akron, Ohio  44309-2090
Barberton Citizens Hospital Barberton, Ohio  44203
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center Reading, Pennsylvania  19612-6052
York Cancer Center at Apple Hill Medical Center York, Pennsylvania  17405
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center Murray, Utah  84157
Schiffler Cancer Center at Wheeling Hospital Wheeling, West Virginia  26003
Saint Louis University Cancer Center Saint Louis, Missouri  63110
Enloe Cancer Center at Enloe Medical Center Chico, California  95926
Radiological Associates of Sacramento Medical Group, Incorporated Sacramento, California  95815
Queen's Cancer Institute at Queen's Medical Center Honolulu, Hawaii  96813
Parkview Regional Cancer Center at Parkview Health Fort Wayne, Indiana  46805
Elliot Regional Cancer Center at Elliot Hospital Manchester, New Hampshire  03103
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Regional Cancer Center at Oconomowoc Memorial Hospital Oconomowoc, Wisconsin  53066
Kinston Medical Specialists Kinston, North Carolina  28501
Cancer Centers of the Carolinas - Faris Road Greenville, South Carolina  29605
Cancer Centers of the Carolinas - Seneca Seneca, South Carolina  29672
Cancer Centers of the Carolinas - Spartanburg Spartanburg, South Carolina  29307
Regional Cancer Center - Erie Erie, Pennsylvania  16505
Cancer Institute at St. John's Hospital Springfield, Illinois  62701
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
University of Wisconcin Cancer Center at Aspirus Wausau Hospital Wausau, Wisconsin  54401
Solano Radiation Oncology Center Vacaville, California  95687
Tyler Cancer Center Tyler, Texas  75702
Center for Cancer Care and Research at Watson Clinic, LLP Lakeland, Florida  33805
Mercy General Hospital Sacramento, California  95819
Memorial Medical Center Modesto, California  95355
Hawaii Medical Center - East Honolulu, Hawaii  96817
Center for Cancer Care at Exeter Hospital Exeter, New Hampshire  03833
Cancer Institute of Cape Girardeau, LLC Cape Girardeau, Missouri  63703
J. Phillip Citta Regional Cancer Center at Community Medical Center Toms River, New Jersey  08755
Veterans Affairs Medical Center - Milwaukee Milwaukee, Wisconsin  53295
Hudner Oncology Center at Saint Anne's Hospital - Fall River Fall River, Massachusetts  02721
Alamance Cancer Center at Alamance Regional Medical Center Burlington, North Carolina  27216
Frankford Hospital Cancer Center - Torresdale Campus Philadelphia, Pennsylvania  19114
Minnesota Oncology - Maplewood Maplewood, Minnesota  55109
UPMC Cancer Center at Beaver Medical Center Beaver, Pennsylvania  15009
UPMC Cancer Center at Jefferson Regional Medical Center Clairton, Pennsylvania  15025
UPMC Cancer Center - Arnold Palmer Pavilion Greensburg, Pennsylvania  15601
UPMC - Shadyside Pittsburgh, Pennsylvania  15213-2582
UPMC Cancer Center at UPMC St. Margaret Pittsburgh, Pennsylvania  15215
UPMC Cancer Center at UPMC Passavant Pittsburgh, Pennsylvania  15237
UPMC Cancer Center at UPMC Northwest Seneca, Pennsylvania  16346
New York Oncology Hematology, PC at Albany Regional Cancer Care Albany, New York  12208
Auburn Radiation Oncology Auburn, California  95603
Radiation Oncology Centers - Cameron Park Cameron Park, California  95682
Radiation Oncology Center - Roseville Roseville, California  95661
Saint John's Cancer Center at Saint John's Medical Center Anderson, Indiana  46016
Northwest Cancer Specialists at Vancouver Cancer Center Vancouver, Washington  98684
Mercy Cancer Center at Mercy San Juan Medical Center Carmichael, California  95608
St. Agnes Hospital Cancer Center Baltimore, Maryland  21229
Southwest General Health Center Middleburgh Heights, Ohio  44130
UHHS Chagrin Highlands Medical Center Orange Villager, Ohio  44122
UHHS Westlake Medical Center Westlaker, Ohio  44145
Longview Cancer Center Longview, Texas  75601
Lakeside Hospital Omaha, Nebraska  68130
Clackamas Radiation Oncology Center Clackamas, Oregon  97015
Radiation Oncology Associates Southwest Fort Wayne, Indiana  46804
Central Indiana Cancer Centers - East Indianapolis, Indiana  46219
Payson Center for Cancer Care at Concord Hospital Concord, New Hampshire  03301
Seacoast Cancer Center at Wentworth - Douglass Hospital Dover, New Hampshire  03820
Willamette Valley Cancer Center - Eugene Eugene, Oregon  97401
Northmain Radiation Oncology Providence, Rhode Island  02904
Texas Oncology, PA at Harris Center HEB Bedford, Texas  76022
Texas Oncology, PA at Texas Cancer Center - Denton South Denton, Texas  76210
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital Fort Worth, Texas  76104
Cancer Care Centers of South Texas - Northeast San Antonio, Texas  78217
Texas Oncology, PA at Texas Cancer Center - Sherman Sherman, Texas  75090
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land Sugar Land, Texas  77479
Bloomington Hospital Regional Cancer Institute Bloomington, Indiana  47403
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center Sleepy Hollow, New York  10591
Arizona Oncology - Tucson Tucson, Arizona  85704
Rocky Mountain Cancer Centers - Aurora Aurora, Colorado  80012
Door County Cancer Center at Door County Memorial Hospital Sturgeon Bay, Wisconsin  54235-1495
Adams Cancer Center Gettysburg, Pennsylvania  17325
Robinson Radiation Oncology Ravenna, Ohio  44266
Saint Agnes Cancer Center at Saint Agnes Medical Center Fresno, California  93720
Memorial Hermann Hospital - Memorial City Houston, Texas  77024
Texas Oncology, PA - Wichita Falls Wichita Falls, Texas  76310