Know Cancer

or
forgot password

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 - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Minnesota Oncology Hematology, PA - MaplewoodMaplewood, Minnesota  55109
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Minnesota Oncology Hematology, PA - WoodburyWoodbury, Minnesota  55125
Aultman Cancer Center at Aultman HospitalCanton, Ohio  44710-1799
Mercy Cancer Center at Mercy Medical CenterCanton, Ohio  44708
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Marshfield Clinic - Indianhead CenterRice Lake, Wisconsin  54868
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Wesley Medical CenterWichita, Kansas  67214
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Overlook HospitalSummit, New Jersey  07902-0220
Carol G. Simon Cancer Center at Morristown Memorial HospitalMorristown, New Jersey  07962
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
McCreery Cancer Center at Ottumwa RegionalOttumwa, Iowa  52501
Our Lady of Mercy Medical Center Comprehensive Cancer CenterBronx, New York  10466
Southwest Medical CenterLiberal, Kansas  67901
Swedish-American Regional Cancer CenterRockford, Illinois  61104-2315
Gundersen Lutheran Center for Cancer and BloodLa Crosse, Wisconsin  54601
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorhees, New Jersey  08043
Hematology Oncology Associates - SkokieSkokie, Illinois  60076
UPMC Cancer CentersPittsburgh, Pennsylvania  15232
Hematology and Oncology AssociatesChicago, Illinois  60611
Midwest Center for Hematology/OncologyJoliet, Illinois  60432
North Shore Oncology and Hematology Associates, Limited - LibertyvilleLibertyville, Illinois  60048
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Capitol HospitalDes Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Immanuel Medical CenterOmaha, Nebraska  68122
Creighton University Medical CenterOmaha, Nebraska  68131-2197
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Pottstown Memorial Regional Cancer CenterPottstown, Pennsylvania  19464
Mercy Cancer Center at Mercy Medical Center - North IowaMason City, Iowa  50401
Cancer Resource Center - LincolnLincoln, Nebraska  68510
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
La Grange Oncology Associates - GenevaNaperville, Illinois  60563
Cancer Care and Hematology Specialists of Chicagoland - NilesNiles, Illinois  60714
McFarland Clinic, PCAmes, Iowa  50010
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Lawrence Memorial HospitalLawrence, Kansas  66044
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Union Hospital Cancer Program at Union HospitalElkton MD, Maryland  21921
Alegant Health Cancer Center at Bergan Mercy Medical CenterOmaha, Nebraska  68124
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
St. Luke's Cancer Network at St. Luke's HospitalBethlehem, Pennsylvania  18015
McGlinn Family Regional Cancer Center at Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Hematology and Oncology Associates of Northeastern PennsylvaniaScranton, Pennsylvania  18510
Center for Cancer Treatment & Prevention at Sacred Heart HospitalEau Claire, Wisconsin  54701
Marshfield Clinic Cancer Care at Regional Cancer CenterEau Claire, Wisconsin  54701
Saint Joseph's HospitalMarshfield, Wisconsin  54449
Marshfield Clinic - Lakeland CenterMinocqua, Wisconsin  54548
Ministry Medical Group at Saint Mary's HospitalRhinelander, Wisconsin  54501
Saint Michael's Hospital Cancer CenterStevens Point, Wisconsin  54481
Marshfield Clinic - Wausau CenterWausau, Wisconsin  54401
Marshfield Clinic - Weston CenterWeston, Wisconsin  54476
Marshfield Clinic - Wisconsin Rapids CenterWisconsin Rapids, Wisconsin  54494
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Cancer Center of Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
CCOP - Main Line HealthWynnewood, Pennsylvania  19096