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A Phase II Study of Neo-Adjuvant Therapy With Oxaliplatin, Leucovorin, 5-Fluorouracil, Panitumumab (Vectibix) and Radiation in Patients With Locally Advanced Adenocarcinoma of the Esophagus or Gastroesophageal Junction

Phase 2
19 Years
Open (Enrolling)
Adenocarcinoma of the Esophagus, Adenocarcinoma of the Gastroesophageal Junction, Stage II Esophageal Cancer

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Trial Information

A Phase II Study of Neo-Adjuvant Therapy With Oxaliplatin, Leucovorin, 5-Fluorouracil, Panitumumab (Vectibix) and Radiation in Patients With Locally Advanced Adenocarcinoma of the Esophagus or Gastroesophageal Junction


I. To determine the pathologic complete response rate of a modified FOLFOX-6 regimen
(leucovorin calcium, fluorouracil, and oxaliplatin) given with panitumumab at two-week
intervals x 4 cycles in combination with external beam radiation therapy for patients with
locally advanced adenocarcinoma of the esophagus.


I. To determine the toxicities and ability to complete the planned treatment. II. To
determine the achieved steady-state plasma concentrations of 5-FU (fluorouracil) and
correlate these with clinical toxicity.

III. To assess the potential importance of polymorphic variations in genomic
deoxyribonucleic acid (DNA) of pertinent genes whose protein products are the targets of the
anti-neoplastic drugs used in the clinical protocol on response and toxicity to therapy.


Patients receive panitumumab intravenously (IV) over 1 hour on day 1. Patients also receive
oxaliplatin IV and leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over
46 hours on day 1 (FOLFOX chemotherapy). Treatment repeats every 2 weeks for 4 courses in
the absence of disease progression or unacceptable toxicity. Within 24 hours of the start of
chemotherapy, patients undergo radiation therapy 5 days a week for 5.5 weeks. Patients then
undergo surgery within 6-8 weeks after completion of chemotherapy and radiation therapy.
Patients with residual disease receive 4 additional courses of FOLFOX chemotherapy.

After completion of study treatment, patients are followed up every 3 months.

Inclusion Criteria:

- Patients must have resectable adenocarcinoma of the esophagus or GE-junction and are
medically fit to undergo surgery; patients must have no evidence of distant
metastasis based on imaging studies

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- Absolute neutrophil count (ANC) of at least 2000 per mcL

- Platelet count of at least 100,000 per mcL

- Serum creatinine less than or equal to 2.0 mg/dL

- Serum magnesium greater than or equal to 1.8 mg/dL

- Total bilirubin less than or equal to 2.0 mg per dL

- Measurable disease is not required for this study, since the primary endpoint is
complete pathologic response

- The patient must be aware of the neoplastic nature of his/her disease and willingly
provide written, informed consent after being informed of the procedure to be
followed, the experimental nature of the therapy, alternatives, potential benefits,
side-effects, risks, and discomforts

Exclusion Criteria:

- Prior therapy: patients with prior history of mediastinal radiation exposure will be
ineligible; patients may not have received prior chemotherapy, or antibody therapy
for esophageal or GE-Junction adenocarcinoma

- History of allergy to platinum compounds or to antiemetics appropriate for
administration in conjunction with protocol-directed chemotherapy

- Patients with a prior history of marked intolerance to 5-fluoropyrimidines (5-FU,
floxuridine, capecitabine, 5-fluorocytosine [flucytosine]), since such patients may
have deficiency of dihydropyrimidine dehydrogenase, which places them at risk for
severe and life-threatening toxicity with 5-FU

- Uncontrolled inter-current illness including, but not limited to ongoing or active
infection requiring intravenous antibiotics, ongoing immunosuppressive therapy
(except for replacement steroids), active human immunodeficiency virus (HIV)
infection, that might jeopardize the ability of the patient to receive the
chemotherapy program outlined in this protocol with reasonable safety

- Clinically significant cardiac disease (including symptomatic congestive heart
failure, myocardial infarction, unstable angina pectoris, or serious, uncontrolled
cardiac arrhythmia) within 1 year of study enrollment

- Pregnant and nursing women, or women planning to become pregnant within 6 months
after the end of treatment, are excluded from this study; a negative pregnancy test
will be required of women of child-bearing age within 72 hours of study enrollment;
subjects (male or female) who are not willing to use highly effective methods of
contraception (per institutional standard) during treatment and for 6 months (male or
female) after the end of treatment are excluded

- History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or
evidence of interstitial lung disease on baseline chest computed tomography (CT)
scan, since the risk of radiation-associated pneumonitis would be increased in such

- Patients with prior malignancy will be excluded except for adequately treated basal
cell or squamous cell skin cancer, adequately treated noninvasive carcinomas, or
other cancers from which the patient has been disease-free for at least 5 years

- Patients receiving an investigational agent within 30 days before enrollment

Type of Study:


Study Design:

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

Outcome Measure:

Complete pathological response (pCR) rate

Outcome Description:

Based on the proportion who achieve pCR. Evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 guidelines.

Outcome Time Frame:

After 4 courses of protocol therapy

Safety Issue:


Principal Investigator

Jean Grem

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Nebraska


United States: Food and Drug Administration

Study ID:




Start Date:

February 2011

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Esophagus
  • Adenocarcinoma of the Gastroesophageal Junction
  • Stage II Esophageal Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Esophageal Diseases
  • Esophageal Neoplasms



UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680