Combination Chemotherapy, Radiation Therapy and Surgery for Esophageal Cancer

Squamous Cell Carcinoma of Esophagus Clinical Trial

Official title:

Phase II Trial of Cetuximab, Irinotecan, Cisplatin (CPC), Concurrent Radiation Therapy, and Surgery for Resectable Esophageal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00165490
• Other study ID #: 02-012
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: November 7, 2014
• Start date: August 2004
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: November 2014
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Esophagus
• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Squamous Cell Carcinoma of Esophagus

Intervention

Drug:
• Cetuximab
Given once per week on weeks 1-8 and restarted 4 weeks after surgery, once weekly for 6 months.
• Cisplatin
Given once per week on weeks 1, 2, 4,and 5.
• Irinotecan
Given once per week on weeks 1, 2, 4,and 5.

Device:
• Radiation therapy
Once daily for 28 treatments (5 1/2 weeks)

Procedure:
• Surgery
Surgery performed 4-8 weeks after chemoradiation therapy.

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the response to the combination of cetuximab, cisplatin, irinotecan, and radiation therapy in resectable esophageal carcinoma.		3 years	No
Secondary	To determine the safety of the drug combination and radiation therapy		3 years	Yes
Secondary	To determine the progression-free survival of patients treated with combination chemotherapy and radiation therapy.		TBD	No