NCT00165490

Combination Chemotherapy, Radiation Therapy and Surgery for Esophageal Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Adenocarcinoma of Esophagus
• Squamous Cell Carcinoma of Esophagus

Interventions

Type	Name	Description
DRUG	Cetuximab	Given once per week on weeks 1-8 and restarted 4 weeks after surgery, once weekly for 6 months.
DRUG	Cisplatin	Given once per week on weeks 1, 2, 4,and 5.
DRUG	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.

Timeline

• Start date: 2004-08-01
• Primary completion: 2007-11-01
• Completion: 2014-11-01
• First posted: 2005-09-14
• Last updated: 2014-11-10

Locations

2 sites across 1 country: United States