Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer



Status:Active, not recruiting
Conditions:Cancer, Gastrointestinal
Therapuetic Areas:Gastroenterology, Oncology
Healthy:No
Age Range:18 - 74
Updated:4/17/2018
Start Date:June 2008
End Date:April 2020

Use our guide to learn which trials are right for you!

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

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal
antibodies, such as cetuximab, can block tumor growth in different ways. Some block the
ability of tumor cells to grow and spread. Others find tumor cells and help kill them or
carry tumor-killing substances to them. Cetuximab may stop the growth of esophageal cancer by
blocking blood flow to the tumor. It is not yet known whether giving paclitaxel and cisplatin
together with radiation therapy is more effective with or without cetuximab in treating
esophageal cancer.

PURPOSE: This randomized phase III trial is comparing how well giving paclitaxel and
cisplatin together with radiation therapy works with or without cetuximab in treating
patients with locally advanced esophageal cancer.

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 (ECS) score of the Functional Assessment of
Cancer Therapy - Esophagus (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.

Inclusion Criteria:

1. 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.

2. 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.)

3. Zubrod performance status 0-2

4. Age ≥ 18 and ≤ 74 (upper limit was set at 74 in an amendment)

5. 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.)

6. 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

7. Patient's total intake (oral/enteral) must be ≥ 1500 kCal/day

8. Patient must provide study-specific informed consent prior to study entry

9. Women of childbearing potential and male participants must practice adequate
contraception

Exclusion Criteria:

1. 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.

2. 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).

3. Prior systemic chemotherapy for esophageal cancer; note that prior chemotherapy for a
different cancer is allowable.

4. Prior radiation therapy that would result in overlap of planned radiation therapy
fields.

5. Prior therapy that specifically and directly targets the epidermal growth factor
receptor (EGFR) pathway.

6. Prior platinum-based and/or paclitaxel-based therapy.

7. Prior allergic reaction to the study drugs involved in this protocol.

8. Prior severe infusion reaction to a monoclonal antibody.

9. 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.

10. 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.

11. Women who are nursing.
We found this trial at
174
sites
2600 6th Street Southwest
Canton, Ohio 44710
330-452-9911
Aultman Cancer Center at Aultman Hospital Serving Stark and surrounding counties since 1892, Aultman Hospital...
?
mi
from
Canton, OH
Click here to add this to my saved trials
86 Jonathan Lucas Street
Charleston, South Carolina 29425
(843) 792-0700
Hollings Cancer Center at Medical University of South Carolina Located at the Medical University of...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
200 Hawthorne Lane
Charlotte, North Carolina 28233
704-384-4000
Presbyterian Cancer Center at Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming...
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
675 N Saint Clair St # 21-100
Chicago, Illinois 60611
(312) 695-1156
Robert H. Lurie Comprehensive Cancer Center at Northwestern University The cancer center was first established...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
2500 Metrohealth Dr # C2100
Cleveland, Ohio 44109
(216) 778-5802
MetroHealth Cancer Care Center at MetroHealth Medical Center At the MetroHealth Cancer Care Center, we...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
1376 Mowry Road
Gainesville, Florida 32610
(352) 273-8010
University of Florida Shands Cancer Center We are the University of Florida Health Cancer Center
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
1920 Libal Street
Green Bay, Wisconsin 54307
(920) 433-8889
St. Vincent Hospital Regional Cancer Center Our group of 19 oncologists, including the region's only...
?
mi
from
Green Bay, WI
Click here to add this to my saved trials
900 West Faris Road
Greenville, South Carolina 29605
(864) 679-3900
Cancer Centers of the Carolinas - Faris Road Cancer Centers of the Carolinas is now...
?
mi
from
Greenville, SC
Click here to add this to my saved trials
33 Villa Road, Suite 400
Greenville, South Carolina 29615
(864) 404-2045
CCOP - Greenville Cancer care in the last decade has made many advances. Most of...
?
mi
from
Greenville, SC
Click here to add this to my saved trials
19229 Mack Ave
Grosse Pointe Woods, Michigan 48236
(866) 246-4673
Van Elslander Cancer Center at St. John Hospital and Medical Center We built the Van...
?
mi
from
Grosse Pointe Woods, MI
Click here to add this to my saved trials
701 Ilalo Street Suite 600
Honolulu, Hawaii 96813
808-586-3010
Cancer Research Center of Hawaii The University of Hawaii Cancer Center is the only National...
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
2500 N. State St.
Jackson, Mississippi 39216
(601) 815-6802
University of Mississippi Cancer Clinic he Cancer Institute is home to the ACT Tobacco Treatment,...
?
mi
from
Jackson, MS
Click here to add this to my saved trials
1240 S Old Dixie Hwy
Jupiter, Florida 33458
(561) 263-4400
Ella Milbank Foshay Cancer Center at Jupiter Medical Center The Foshay Cancer Center is one...
?
mi
from
Jupiter, FL
Click here to add this to my saved trials
200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
701 Doctors Dr
Kinston, North Carolina 28504
(252) 559-2200
Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
?
mi
from
Kinston, NC
Click here to add this to my saved trials
?
mi
from
Lakeland, FL
Click here to add this to my saved trials
One Medical Center Drive
Lebanon, New Hampshire 03756
(603) 653-9000
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Norris Cotton Cancer Center at DHMC in...
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
4300 Alton Road
Miami Beach, Florida 33140
(305) 674-2625
CCOP - Mount Sinai Medical Center The Mount Sinai Community Clinical Oncology Program (MSCCOP) is...
?
mi
from
Miami Beach, FL
Click here to add this to my saved trials
326 Washington Street
Norwich, Connecticut 06360
860-892-6936
?
mi
from
Norwich, CT
Click here to add this to my saved trials
800 NE 10th Street
Oklahoma City, Oklahoma 73104
(855) 750-2273
Oklahoma University Cancer Institute The Peggy and Charles Stephenson Cancer Center is located on the...
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
1400 South Orange Avenue
Orlando, Florida 32806
(407) 648-3800
M.D. Anderson Cancer Center at Orlando For more than twenty years, our cancer center has...
?
mi
from
Orlando, FL
Click here to add this to my saved trials
593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Comprehensive Cancer Center The Comprehensive Cancer Center at Rhode Island Hospital is...
?
mi
from
Providence, RI
Click here to add this to my saved trials
2279 45th Street
Sacramento, California 95817
(916) 734-5800
University of California Davis Cancer Center At UC Davis Comprehensive Cancer Center, specialized teams of...
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
131 Lila Doyle Drive
Seneca, South Carolina 29672
(864) 888-3717
Cancer Centers of the Carolinas - Seneca Cancer Centers of the Carolinas is now Cancer...
?
mi
from
Seneca, SC
Click here to add this to my saved trials
120 Dillon Dr
Spartanburg, South Carolina 29307
(864) 699-5700
Cancer Centers of the Carolinas - Spartanburg Cancer Centers of the Carolinas is now Cancer...
?
mi
from
Spartanburg, SC
Click here to add this to my saved trials
42 E Laurel Rd # 2545
Voorhees, New Jersey 08043
(800) 826-6737
Cancer Institute of New Jersey at Cooper - Voorhees Cooper University Health Care, the clinical...
?
mi
from
Voorhees, NJ
Click here to add this to my saved trials
161 North Forge Street
Akron, Ohio 44304
(330) 375-7280
Summa Center for Cancer Care at Akron City Hospital Summa Health System is a leader...
?
mi
from
Akron, OH
Click here to add this to my saved trials
1 Akron General Ave
Akron, Ohio 44307
(330) 344-6000
McDowell Cancer Center at Akron General Medical Center Learning that you or someone you love...
?
mi
from
Akron, OH
Click here to add this to my saved trials
?
mi
from
Albany, NY
Click here to add this to my saved trials
Amarillo, Texas 79106
?
mi
from
Amarillo, TX
Click here to add this to my saved trials
Ames, Iowa 50010
McFarland Clinic, PC It has been over 65 years since the founders of McFarland Clinic...
?
mi
from
Ames, IA
Click here to add this to my saved trials
?
mi
from
Anderson, IN
Click here to add this to my saved trials
5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-4673
Saint Joseph Mercy Cancer Center Saint Joseph Mercy Health System is one of Michigan's most...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Asheville, North Carolina 28801
?
mi
from
Asheville, NC
Click here to add this to my saved trials
Auburn, California 95603
?
mi
from
Auburn, CA
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
900 Caton Ave.
Baltimore, Maryland 21229
410-368-6000
St. Agnes Hospital Cancer Center Saint Agnes Hospital is leading Maryland in the battle against...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
6701 North Charles Street
Baltimore, Maryland 21204
443-849-3051
Greater Baltimore Medical Center Cancer Center The Sandra & Malcolm Berman Cancer Institute's comprehensive, multidisciplinary...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Barberton, Ohio 44203
?
mi
from
Barberton, OH
Click here to add this to my saved trials
4950 Essen Ln
Baton Rouge, Louisiana 70809
(225) 767-0847
Mary Bird Perkins Cancer Center - Baton Rouge Mary Bird Perkins Cancer Center (MBPCC) and...
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
Beaver, Pennsylvania 15009
?
mi
from
Beaver, PA
Click here to add this to my saved trials
?
mi
from
Bedford, TX
Click here to add this to my saved trials
1233 34th St NW
Bemidji, Minnesota 56601
(218) 333-5000
MeritCare Bemidji Sanford Health is an integrated health system headquartered in the Dakotas and is...
?
mi
from
Bemidji, MN
Click here to add this to my saved trials
Billings, Montana 59107
?
mi
from
Billings, MT
Click here to add this to my saved trials
Binghamton, New York 13905
?
mi
from
Binghamton, NY
Click here to add this to my saved trials
?
mi
from
Bloomington, IN
Click here to add this to my saved trials
1055 N Curtis Rd
Boise, Idaho 83706
(208) 367-2121
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Saint Alphonsus Health System...
?
mi
from
Boise, ID
Click here to add this to my saved trials
?
mi
from
Burlington, NC
Click here to add this to my saved trials
Cameron Park, California 95682
?
mi
from
Cameron Park, CA
Click here to add this to my saved trials
?
mi
from
Canton, OH
Click here to add this to my saved trials
Cape Girardeau, Missouri 63703
?
mi
from
Cape Girardeau, MO
Click here to add this to my saved trials
?
mi
from
Carmichael, CA
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Chico, CA
Click here to add this to my saved trials
9280 SE Sunnybrook Blvd #100
Clackamas, Oregon 97015
(503) 513-3300
Clackamas Radiation Oncology Center State-of-the-art technology and compassionate care come together at Clackamas Radiation Oncology...
?
mi
from
Clackamas, OR
Click here to add this to my saved trials
?
mi
from
Clairton, PA
Click here to add this to my saved trials
11100 Euclid Avenue
Cleveland, Ohio 44106
216.844.8797
Case Comprehensive Cancer Center The Case Comprehensive Cancer Center (Case CCC) based at Case Western...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
1831 Fifth Avenue
Columbus, Georgia 31904
(706) 320-8700
John B. Amos Cancer Center The John B. Amos Cancer Center located in Columbus, Georgia,...
?
mi
from
Columbus, GA
Click here to add this to my saved trials
?
mi
from
Concord, NH
Click here to add this to my saved trials
11850 Blackfoot St. NW Suite 130
Coon Rapids, Minnesota 55433
763-236-0808
Mercy and Unity Cancer Center at Mercy Hospital The Virginia Piper Cancer Institute - Mercy...
?
mi
from
Coon Rapids, MN
Click here to add this to my saved trials
?
mi
from
Denton, TX
Click here to add this to my saved trials
2525 S Downing St
Denver, Colorado 80210
(303) 778-1955
Porter Adventist Hospital Founded in 1930, Porter Adventist Hospital has provided people throughout Denver and...
?
mi
from
Denver, CO
Click here to add this to my saved trials
1221 Pleasant St
Des Moines, Iowa 50309
(515) 241-4141
John Stoddard Cancer Center at Iowa Methodist Medical Center Iowa's first children's cancer center opened...
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
411 Laurel Street
Des Moines, Iowa 50314
(515) 247-3121
Mercy Cancer Center at Mercy Medical Center - Des Moines When it comes to cancer...
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
2799 W Grand Blvd
Detroit, Michigan 48202
(888) 777-4167
Josephine Ford Cancer Center at Henry Ford Hospital A diagnosis of cancer is one of...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Dover, NH
Click here to add this to my saved trials
?
mi
from
Drexel Hill, PA
Click here to add this to my saved trials
Erie, Pennsylvania 16505
?
mi
from
Erie, PA
Click here to add this to my saved trials
?
mi
from
Eugene, OR
Click here to add this to my saved trials
Exeter, New Hampshire 03833
?
mi
from
Exeter, NH
Click here to add this to my saved trials
?
mi
from
Fall River, MA
Click here to add this to my saved trials
820 4th Street North
Fargo, North Dakota 58122
(701) 234-6292
CCOP - MeritCare Hospital The Sanford Community Cancer Consortium is a "newly" formed CCOP, merging...
?
mi
from
Fargo, ND
Click here to add this to my saved trials
302 Kensington Ave
Flint, Michigan 48503
(810) 762-8490
Genesys Hurley Cancer Institute Bringing the most advanced cancer treatment services, technologies and programs available...
?
mi
from
Flint, MI
Click here to add this to my saved trials
?
mi
from
Fort Wayne, IN
Click here to add this to my saved trials
Fort Wayne, Indiana 46804
?
mi
from
Fort Wayne, IN
Click here to add this to my saved trials
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
?
mi
from
Fresno, CA
Click here to add this to my saved trials
?
mi
from
Fresno, CA
Click here to add this to my saved trials
40 V-Twin Drive
Gettysburg, Pennsylvania 17325
(717) 339-2640
Adams Cancer Center Every day across central Pennsylvania, the people of WellSpan Health work together...
?
mi
from
Gettysburg, PA
Click here to add this to my saved trials
100 Park Street
Glens Falls, New York 12801
518.926.1000
Charles R. Wood Cancer Center at Glens Falls Hospital Glens Falls Hospital is the largest...
?
mi
from
Glens Falls, NY
Click here to add this to my saved trials
250 Cherry St SE
Grand Rapids, Michigan 49503
(616) 685-5225
Lacks Cancer Center at Saint Mary's Health Care Mercy Health Lacks Cancer Center was one...
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
1101 26th Street South
Great Falls, Montana 59405
406.455.5000
Sletten Cancer Institute at Benefis Healthcare Benefis Hospitals has 516 beds at its two campuses...
?
mi
from
Great Falls, MT
Click here to add this to my saved trials
?
mi
from
Green Bay, WI
Click here to add this to my saved trials
Greensburg, Pennsylvania 15601
?
mi
from
Greensburg, PA
Click here to add this to my saved trials
2226 Liliha St
Honolulu, Hawaii 96817
(808) 547-6011
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
1301 Punchbowl Street
Honolulu, Hawaii 96813
(808) 538-9011
Queen's Cancer Institute at Queen's Medical Center The Queen
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Indianapolis, Indiana 46219
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Keene, NH
Click here to add this to my saved trials
1915 White Ave.
Knoxville, Tennessee 37916
(865) 541-1678
Thompson Cancer Survival Center The Thompson Cancer Survival Center Downtown facility has pioneered many advances...
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
36475 Five Mile
Livonia, Michigan 48154
734-655-4800
St. Mary Mercy Hospital St. Mary Mercy Hospital, located at 36475 Five Mile Road at...
?
mi
from
Livonia, MI
Click here to add this to my saved trials
Long Branch, New Jersey
?
mi
from
Long Branch, NJ
Click here to add this to my saved trials
Longview, Texas 75601
?
mi
from
Longview, TX
Click here to add this to my saved trials
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Lubbock, TX
Click here to add this to my saved trials
Manchester, New Hampshire 03103
?
mi
from
Manchester, NH
Click here to add this to my saved trials
1580 Beam Ave
Maplewood, Minnesota 55109
(651) 779-7978
Minnesota Oncology - Maplewood At Minnesota Oncology, we join together with you in a firm...
?
mi
from
Maplewood, MN
Click here to add this to my saved trials
3100 Shore Dr.
Marinette, Wisconsin 54143
715.735.6621
Bay Area Cancer Care Center at Bay Area Medical Center The Bay Area Cancer Care...
?
mi
from
Marinette, WI
Click here to add this to my saved trials