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

Phase 2
18 Years
Open (Enrolling)
Adenocarcinoma of Esophagus, Squamous Cell Carcinoma of Esophagus

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Trial Information

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

- 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

- During chemotherapy and radiation therapy, physical exams and vital signs will be
performed before each chemotherapy treatment. Routine blood tests will also be

- 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.

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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

To determine the response to the combination of cetuximab, cisplatin, irinotecan, and radiation therapy in resectable esophageal carcinoma.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Peter Enzinger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

June 2004

Completion Date:

December 2012

Related Keywords:

  • Adenocarcinoma of Esophagus
  • Squamous Cell Carcinoma of Esophagus
  • adenocarcinoma of esophagus
  • squamous cell carcinoma of esophagus
  • combination chemotherapy
  • cisplatin
  • irinotecan
  • radiation therapy
  • resectable esophageal cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Esophageal Diseases
  • Esophageal Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617