Panitumumab, Docetaxel, Cisplatin, Radiation Therapy, and Surgery in Treating Patients With Newly Diagnosed, Locally Advanced Esophageal Cancer or Cancer of the Gastroesophageal Junction

This is an interventional treatment trial for Adenocarcinoma of the Gastroesophageal Junction focused on measuring adenocarcinoma of the esophagus, adenocarcinoma of the gastroesophageal junction, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer Read More

1. ≥ 18 years old
2. ECOG/Zubrod Performance Status 0-1

3. Biopsy-proven resectable primary (nonrecurrent) adenocarcinoma of the distal esophagus or GE junction (Siewert Type I or II)

   • Siewert Type I: adenocarcinoma of the distal esophagus
   • Siewert Type II: adenocarcinoma of the esophago-gastric junction/real cardia
4. Pre-registration EUS, CT of chest and upper abdomen, and PET must support a clinical stage of T3N0M0, T2-3N1M0 or T2-3N0-1M1a (celiac adenopathy must be ≤ 2 cm by EUS). Clinically staged T1 tumors and T2N0M0 tumors are not eligible. N1 does not require biopsy/FNA. Note: Patients requiring a stent for nutrition must have staging examinations and scans completed before stent placement.
5. No definitive radiological evidence of distant metastases.
6. No pre-existing grade 2 or greater peripheral neuropathy (CTCAE v3) of any etiology.

7. Adequate bone marrow, hepatic and renal function prior to registration:

   • WBC ≥ 3,000/mm³
   • ANC ≥ 1,500/mm³
   • Platelet count ≥ 100,000/mm³
   • Hemoglobin ≥ 9.5 g/dL
   • Creatinine ≤ 1.5 mg/dL
   • Total bilirubin ≤ 3 mg/dL
   • AST (SGOT) ≤ 2.0 times upper limit of normal (ULN)
   • ALT (SGPT) ≤ 2.0 times ULN
   • Alkaline phosphatase ≤ 2.0 times ULN
   • Albumin ≥ 2.0 g/dL OR prealbumin ≥ 15 mg/dL
   • Magnesium ≥ lower limit of normal (LLN)
8. Patient must be evaluated before registration by medical oncologist, radiation oncologist and surgeon and deemed fit for protocol therapy and surgery.
9. No prior invasive malignancy, unless disease-free for ≥ 5 years prior to registration (Exceptions: non-melanoma skin cancer, in-situ cancers).
10. Non-pregnant and non-breast feeding. Female participants of child-bearing potential must have a negative urine or serum pregnancy test prior to registration. Perimenopausal participants must be amenorrheic ≥ 12 months to be considered not of childbearing potential. All patients of reproductive potential must agree to use an an effective method of birth-control while receiving study therapy and for six months after completion of therapy.
11. No prior chest or upper abdomen radiotherapy; prior therapy with cisplatin, docetaxel, panitumumab or other anti-EGFR therapy or prior esophageal or gastric surgery (Exception: prior surgery to treat reflux disease)
12. No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psyschiatric illness/social situations that would limit compliance with study requirements.
13. No history of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis or any evidence of interstitial lung disease on baseline chest CT scan
14. No history of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the study participation or investigational product(s) administration or may interfere with the interpretation of the results.