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A Phase I/II Study of Panitumumab, Capecitabine and Oxaliplatin Chemotherapy With External Beam Radiation Therapy for the Treatment of Resectable, Locally Advanced/Unresectable or Metastatic Esophageal Cancer

Phase 1/Phase 2
18 Years
82 Years
Not Enrolling
Cancer of the Esophagus

Thank you

Trial Information

A Phase I/II Study of Panitumumab, Capecitabine and Oxaliplatin Chemotherapy With External Beam Radiation Therapy for the Treatment of Resectable, Locally Advanced/Unresectable or Metastatic Esophageal Cancer

This study has a phase I/II design. For this study the administration of panitumumab is
considered investigational.

Pretreatment: Part of regular cancer care and disease staging includes Chest/Abdomen CT
Scan, upper endoscopic ultrasound, PET scan, J-Tube Placement (if clinically indicated),
bronchoscopy (per clinician judgment), ECG, and baseline laboratory studies.

During Treatment Weeks 1-5.5 of Radiation Therapy(RT)/Chemotherapy:

- RT (180 cGy/fx, Mon-Fri) days 1-5, 8-12, 15-19, 22-26, 29-33 and 36-38.

- Panitumumab (per dose level) days 1, 15, 29.

- Oxaliplatin (per dose level) days 1, 8, 15, 22, 29, 36.

- Capecitabine (per dose level M-F) 1-5, 8-12, 15-19, 22-26, 29-33, 36-38.

Inclusion Criteria:

- 18 years of age or older.

- Histologically or cytologically documented squamous cell carcinoma or Siewert's
classification adenocarcinoma of the esophagus or proximal stomach T1-4, N0-2, M0-1,
for which bimodality treatment with chemotherapy and radiation therapy is indicated.

- Measurable Disease

- ECOG Performance Status 0-1

- Laboratory values must be as follows:

- Absolute neutrophil count > or = 2,000/mm3,

- Platelets > or = 100,000/mm3,

- Hemoglobin > 9.0,

- Total bilirubin <1.5 x institutional upper normal limit,

- Serum creatinine <1.5 x institutional upper normal limit,

- AST or ALT < 3x institutional upper normal limit,

- Magnesium equal or higher than institutional lower limit,

- Creatinine clearance Estimated > 40 ml/min,

- Calcium > lower limit of normal.

- Not pregnant or lactating. Negative pregnancy test within 72 hours prior to
registration (female patients of childbearing potential). Postmenopausal woman must
have been amenorrheic for at least 12 months to be considered of non-childbearing

- Life expectancy must be >3 months.

- No serious or poorly controlled medical or psychological conditions that could be
exacerbated by the treatment or would seriously complicate compliance with the

- Able to swallow capecitabine (whole or crushed tablet or liquid dispersed) or
patients may have a G or J tube.

- No conditions that would significantly compromise intestinal absorption of the study

Exclusion Criteria:

- Tumors extending above the level of the thoracic inlet or beyond 5 cm below the
gastroesophageal junction.

- Patients with radiographic or bronchoscopic evidence of esophageal perforation.

- Patients with known evidence of brain metastases, lymphangitic lung metastases, or
carcinomatous meningitis.

- Dementia or significantly altered mental status

- Major surgery within 4 weeks of the start of study treatment

- Prior chemotherapy, radiation therapy, hormonal or biologic therapy within the past 6

- Subjects requiring chronic use of immunosuppressive agents (e.g., methotrexate,
cyclosporine, corticosteroids)

- Currently requiring medications that may interact with the metabolism or disposition
of capecitabine/5-FU: dipyridamole, folinic acid, allopurinol, trimethoprim,
misonidazole, metoclopramide, flucytosine or cimetidine.

- Hypersensitivity to platinum containing compounds or capecitabine or any of the
excipients of this product. Prior unanticipated severe reaction to
fluoropyrimidine/platinum therapy, or known sensitivity to 5-fluorouracil/platinum
containing compounds.

- Serious, uncontrolled, concurrent infection(s).

- History of other disease, metabolic dysfunction, physical examination finding, or
clinical laboratory finding giving reasonable suspicion of a disease or condition
that contraindicates the use of an investigational drug or that might affect the
interpretation of the results of the study or render the subject at high risk from
treatment complications.

- Treatment for other carcinomas within the last five years, except cured non-melanoma
skin and treated in-situ cervical cancer.

- Peripheral neuropathy > grade 1

- Any of the following within 24 weeks before randomization: clinically significant
cardiovascular disease (including myocardial infarction, unstable angina, symptomatic
congestive heart failure, serious uncontrolled cardiac arrhythmia).

- Uncontrolled gastrointestinal ulcer within 28 days of randomization

- History of interstitial pneumonitis or pulmonary fibrosis, or evidence of
interstitial pneumonitis or pulmonary fibrosis on baseline chest X-ray or CT-scan

- Preexisting known bleeding diathesis or coagulopathy

- Plans to continue on or use of ketoconazole, phenytoin, phenobarbital, carbamazepine,
rifampin, rifabutin or St. John's Wort, 14 days prior to randomization.

- History of hypersensitivity to tetracyclines

- Subject known to be human immunodeficiency virus positive

- Subjects known to have chronic or active hepatitis B or C infection

Type of Study:


Study Design:

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

Outcome Measure:

Panitumumab Maximum Tolerated Dose in Milligrams (mg)

Outcome Time Frame:

60 days

Safety Issue:


Principal Investigator

Brian Czito, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University


United States: Food and Drug Administration

Study ID:




Start Date:

December 2007

Completion Date:

June 2012

Related Keywords:

  • Cancer of the Esophagus
  • esophageal cancer
  • Esophageal Diseases
  • Esophageal Neoplasms



Duke University Medical CenterDurham, North Carolina  27710