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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
N/A
Open (Enrolling)
Both
Adenocarcinoma of Esophagus, Squamous Cell Carcinoma of Esophagus

Thank you

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
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.


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.

Type of Study:

Interventional

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:

No

Principal Investigator

Peter Enzinger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

02-012

NCT ID:

NCT00165490

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

Name

Location

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