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Cetuximab Plus Cisplatin, Irinotecan and Thoracic Radiotherapy (TRT) for Locally Advanced (Non-Metastatic), Clinically Unresectable Esophageal Cancer: A Phase II Trial With Molecular Correlates

Phase 2
18 Years
Not Enrolling
Esophageal Cancer

Thank you

Trial Information

Cetuximab Plus Cisplatin, Irinotecan and Thoracic Radiotherapy (TRT) for Locally Advanced (Non-Metastatic), Clinically Unresectable Esophageal Cancer: A Phase II Trial With Molecular Correlates



- Determine the 2-year overall survival of patients with previously untreated, clinically
unresectable, locally advanced squamous cell carcinoma or adenocarcinoma of the
esophagus treated with cetuximab, cisplatin, irinotecan, and thoracic radiotherapy.


- Determine the toxicity profile of this regimen in these patients.

- Determine the probability of objective response (confirmed and unconfirmed, complete
and partial) in patients with measurable disease treated with this regimen.

- Determine the time to progression in patients with measurable disease treated with this

- Correlate, preliminarily, gene expression (RNA) levels and germline polymorphisms of
genes involved in DNA repair (e.g., ECRCC-1 and XRCC-1), drug metabolism (e.g.,
UGT1A1), and the epidermal growth factor receptor (EGFR) pathway (e.g., EGFR,
interleukin-8, and vascular endothelial growth factor) with response, time to
progression, overall survival, and toxicity in patients treated with this regimen.
(This will not be completed as this study was closed due to poor accrual.)

OUTLINE: This is a multicenter study.

Patients receive cetuximab intravenous (IV) over 1-2 hours on days 1, 8, and 15. Patients
also receive cisplatin IV and irinotecan IV over 30 minutes on days 1 and 8. Treatment
repeats every 21 days for 4 courses in the absence of disease progression or unacceptable
toxicity. Beginning on day 1 of course 3, patients undergo thoracic radiotherapy once daily
5 days a week for 5-6 weeks (total of 28 treatments).

After completion of study treatment, patients are followed at 4 weeks and then every 3-6
months for up to 5 years after study entry.

PROJECTED ACCRUAL: A total of 75-100 patients (75 with adenocarcinoma and 25 with squamous
cell carcinoma) will be accrued for this study.

Inclusion Criteria


- Histologically confirmed primary squamous cell carcinoma or adenocarcinoma of the
thoracic esophagus (≥ 20 cm from the incisors*) or the gastroesophageal junction
(confined to ≤ 2 cm into the gastric cardia)

- Disease confined to the esophagus or peri-esophageal soft tissue

- T4, M0 disease

- Surgically unresectable disease by esophageal endoscopic ultrasonography OR
medically unresectable disease

NOTE: *Patients with primary disease < 26 cm from the incisors must undergo bronchoscopy
AND have negative cytology within the past 4 weeks

- Measurable or non-measurable disease by x-ray, CT scan and/or MRI, or physical
examination within the past 4 weeks (for measurable disease) or within the past 6
weeks (for non-measurable disease)

- Tumor specimens available

- No recurrent disease



- 18 and over

Performance status

- Zubrod 0-2

Life expectancy

- Not specified


- Absolute neutrophil count (ANC) ≥ 1,500/mm^3

- White Blood Cell (WBC) count ≥ 3,000/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 10.0 g/dL


- Albumin normal

- Bilirubin normal

- Alkaline phosphatase normal

- Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic pyruvic transaminase
(SGPT) ≤ 2.5 times upper limit of normal


- Creatinine clearance > 50 mL/min


- Not pregnant or nursing

- Fertile patients must use effective contraception

- No prior severe reaction to monoclonal antibodies

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix


Biologic therapy

- Not specified


- No prior chemotherapy for esophageal cancer

Endocrine therapy

- Not specified


- No prior radiotherapy for esophageal cancer

- No concurrent intensity modulated radiotherapy

- No concurrent cobalt-60


- No prior surgical resection or attempted surgical resection of esophageal cancer

Type of Study:


Study Design:

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

Outcome Measure:

Overall Survival at 2 Years

Outcome Description:

Measured from time of registration to date of death due to any cause, or last contact date

Outcome Time Frame:

0-2 years

Safety Issue:


Principal Investigator

Charles R. Thomas, MD

Investigator Role:

Study Chair

Investigator Affiliation:

OHSU Knight Cancer Institute


United States: Federal Government

Study ID:




Start Date:

May 2005

Completion Date:

May 2012

Related Keywords:

  • Esophageal Cancer
  • adenocarcinoma of the esophagus
  • squamous cell carcinoma of the esophagus
  • stage III esophageal cancer
  • Esophageal Diseases
  • Esophageal Neoplasms



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