Combination Chemotherapy, Radiation Therapy and Surgery for Esophageal Cancer - Full Text View

Sponsors and Collaborators:	Dana-Farber Cancer Institute Brigham and Women's Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00165490

Purpose

The purpose of this study is to find out what effects (good and bad) the combination of three chemotherapy drugs (cetuximab, cisplatin, and irinotecan) have on esophageal cancer when given with radiation therapy.

Condition	Intervention	Phase
Adenocarcinoma of Esophagus Squamous Cell Carcinoma of Esophagus	Drug: Cetuximab Drug: Cisplatin Drug: Irinotecan Device: Radiation therapy Procedure: Surgery	Phase II

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Radiation Therapy Surgery

Drug Information available for: Cisplatin Irinotecan U 101440E Irinotecan hydrochloride Cetuximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Trial of Cetuximab, Irinotecan, Cisplatin (CPC), Concurrent Radiation Therapy, and Surgery for Resectable Esophageal Cancer

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To determine the response to the combination of cetuximab, cisplatin, irinotecan, and radiation therapy in resectable esophageal carcinoma. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the safety of the drug combination and radiation therapy [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
To determine the progression-free survival of patients treated with combination chemotherapy and radiation therapy. [ Time Frame: TBD ] [ Designated as safety issue: No ]

Estimated Enrollment:	39
Study Start Date:	June 2004
Estimated Study Completion Date:	November 2009
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Given once per week on weeks 1-8 and restarted 4 weeks after surgery, once weekly for 6 months.

Given once per week on weeks 1, 2, 4,and 5.

Once daily for 28 treatments (5 1/2 weeks)

Surgery performed 4-8 weeks after chemoradiation therapy.

Detailed Description:

Patients participating in this study must have a tumor biopsy taken to confirm the type of tumor.
Outpatient therapy with cetuximab alone will be given intravenously on week 0.
During week 1-8 outpatient radiation therapy will be started and continued once per day for 28 treatments or 5 1/2 weeks.
Outpatient chemotherapy (cisplatin, irinotecan and cetuximab) is given once per week on weeks 1, 2, 4, and 5. Cetuximab alone will be given on weeks 3, 6, 7, and 8.
A repeat CT scan and PET scan will be performed to restage the tumor on week 8. This is to confirm that the cancer has remained localized.
Inpatient surgery is scheduled 4 to 8 weeks after completion of chemotherapy and radiation therapy.
Cetuximab will be restarted within 4 weeks after surgery and continue weekly for 6 months.
During chemotherapy and radiation therapy, physical exams and vital signs will be performed before each chemotherapy treatment. Routine blood tests will also be performed.
Between chemotherapy-radiation therapy and surgery a CAT scan of chest, abdomen and pelvis along with a PET scan will be performed.
After surgery a CAT scan of chest, abdomen and pelvis will be performed every 3 months for 2 years then every 6 months for 3 years. An EGD (upper endoscopy) with biopsy will be done every 6 months for 2 years and then yearly for 3 years. Physical exam, vital signs and routine blood tests will be done every 2 weeks for 6 months, then every 3 months for 1.5 years, and then every 6 months for 3 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years of age or older
Negative pregnancy test
Adenocarcinoma or squamous cell carcinoma of the esophagus, including the gastroesophageal junction, histologically confirmed, stage IIA, IIB and III.
ECOG performance status of 0 or 1.
Neutrophils greater or equal to 1,500/ul
Platelets greater or equal to 100,000/ul
Serum bilirubin less or equal to 1.5mg/ul
Serum creatinine less or equal to 1.5mg/ul
AST or SGOT less or equal to 2.5x upper normal limit
Alkaline phosphatase less or equal to 5x upper normal limit

Exclusion Criteria:

Prior surgery for esophageal or gastro-esophageal junction cancer.
Prior chemotherapy or radiation therapy
Biopsy proven tumor invasion of the tracheobronchial tree or tracheo-esophageal fistula.
Metastatic disease to distant organs or non-regional lymph nodes.
Co-morbid disease that in the opinion of the investigator makes combined chemo-radiotherapy inadvisable.
Pregnant or lactating women
Other active malignancy
Patients with known Gilbert's Disease or interstitial pulmonary fibrosis.
History of seizure disorder
Uncontrolled diarrhea
Peripheral neuropathy (Grade 2)
Prior cetuximab or other therapy that specifically and directly targets the EGF pathway.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165490

Locations

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Investigators

Principal Investigator:

Peter Enzinger, MD

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Dana-Farber Cancer Institute ( Peter Enzinger, MD )
Study ID Numbers:	02-012
Study First Received:	September 9, 2005
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00165490 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

adenocarcinoma of esophagus
squamous cell carcinoma of esophagus
combination chemotherapy
cisplatin

irinotecan
cisplatin
radiation therapy
resectable esophageal cancer

Study placed in the following topic categories:

Digestive System Neoplasms
Gastrointestinal Diseases
Esophageal Neoplasms
Cetuximab
Irinotecan
Esophageal Cancer
Squamous Cell Carcinoma
Carcinoma
Digestive System Diseases
Radiation-Sensitizing Agents
Cisplatin

Esophageal Disorder
Head and Neck Neoplasms
Epidermoid Carcinoma
Gastrointestinal Neoplasms
Esophageal Diseases
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Antineoplastic Agents
Esophageal Neoplasms
Irinotecan
Physiological Effects of Drugs
Neoplasms by Site
Cisplatin
Therapeutic Uses
Neoplasms, Squamous Cell
Digestive System Neoplasms
Neoplasms by Histologic Type
Cetuximab

Enzyme Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases
Carcinoma, Squamous Cell
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 06, 2009