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A Pilot Study With Cetuximab and Radiation Therapy for Patients With Surgically Resectable Esophageal and GE Junction Carcinomas: Hoosier Oncology Group Study (GI05-92)

Phase 2
18 Years
Not Enrolling
Esophageal Cancer

Thank you

Trial Information

A Pilot Study With Cetuximab and Radiation Therapy for Patients With Surgically Resectable Esophageal and GE Junction Carcinomas: Hoosier Oncology Group Study (GI05-92)

OUTLINE: This is a multi-center study.

- Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose)

- Cetuximab 250 mg/m2 IV over 60 minutes, day -7.

- Cetuximab 250 mg/m2 IV over 60 minutes, days 1, 8, 15, 22, 29 and 36.

- External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost
of 540 cGy at 180 cGy per fraction for 6 weeks.

- Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes
by a transthoracic approach after satisfactory hematologic and functional recovery
within 8 weeks of completion of radiation therapy.

- For patients who give their consent, fresh frozen tissue will be obtained per EUS at
baseline, per EUS 2 weeks after the initiation of cetuximab, and at the time of surgery
for pathology submission.

Inclusion Criteria:

- Pathological diagnosis of either squamous cell carcinoma or adenocarcinoma of the
esophagus or gastroesophageal junction.

- Clinical stage IIA, IIB or III without metastatic disease

- Patients must have documented EGFR status or have tumor tissue available for
assessment of EGFR status by IHC

- Patients must be surgical candidates as determined by surgical consult.

- Patients must agree to surgery.

- ECOG performance status 0 or 2

- Absolute neutrophil count (ANC) > 1,000 mm3

- Platelet count > 75,000 mm3· Hemoglobin > 10g/dL

- Bilirubin < 2.5 X upper limit of normal

- AST (SGOT) or ALT (SGPT) < 5.0 ´ upper limit of normal

- Creatinine < 2.0 X upper limit of normal

Exclusion Criteria:

- No history of or current brain metastasis.

- No significant history of uncontrolled cardiac disease; i.e. uncontrolled
hypertension, unstable angina, recent myocardial infarction (within prior 6 months),
uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection

- No history of interstitial pneumonitis or pulmonary fibrosis, or suspicion of
interstitial pneumonitis or pulmonary fibrosis on imaging.

- No concurrent chemotherapy not indicated in the study protocol or any other
investigational agent(s).

- No prior use of radiation or chemotherapy for cancer of the esophagus or GE junction

- No prior therapy that specifically and directly targets the EGFR pathway (such as
kinase inhibitors and antibodies directed against the HER family receptors).

- No prior severe infusion reaction to a monoclonal antibody.

- No major surgery within 28 days prior to being registered for protocol therapy.

- No clinically significant infections as judged by the treating investigator.

- No acute hepatitis or known HIV.

- No other active malignancies.

- Negative pregnancy test.

- No female patients currently breastfeeding.

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 evaluate complete pathologic response rate in patients with esophageal and GE junction carcinomas

Outcome Time Frame:

36 months

Safety Issue:


Principal Investigator

Carlos Becerra, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Hoosier Oncology Group, LLC


United States: Institutional Review Board

Study ID:

HOG GI05-92



Start Date:

April 2006

Completion Date:

January 2009

Related Keywords:

  • Esophageal Cancer
  • Carcinoma
  • Esophageal Diseases
  • Esophageal Neoplasms



Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Texas Southwestern Medical Center at DallasDallas, Texas  75235-8897
Siteman Cancer CenterSaint Louis, Missouri  63110
Texas Oncology, PADallas, Texas  75246-2006
Medical & Surgical Specialists, LLCGalesburg, Illinois  61401
Community Regional Cancer CenterIndianapolis, Indiana  46256
AP&S ClinicTerre Haute, Indiana  47804