Panitumumab, Docetaxel, Cisplatin, Radiation Therapy, and Surgery in Treating Patients With Newly Diagnosed, Locally Advanced Esophageal Cancer or Cancer of the Gastroesophageal Junction
Condition: Adenocarcinoma of the Gastroesophageal Junction; Esophageal Cancer
MeSH terms: Adenocarcinoma; Esophageal Neoplasms
Intervention: panitumumab; cisplatin; docetaxel; neoadjuvant therapy; therapeutic conventional surgery; radiation therapy
Intervention MeSH terms: Docetaxel; Panitumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the esophagus; adenocarcinoma of the gastroesophageal junction; stage II esophageal cancer; stage III esophageal cancer; stage IV esophageal cancer

Summary:

      RATIONALE: Monoclonal antibodies, such as panitumumab, can block tumor growth in different
      ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
      help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as
      cisplatin and docetaxel, work in different ways to kill tumor cells or stop them from
      growing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination
      chemotherapy together with panitumumab and radiation therapy before surgery may make the
      tumor smaller and reduce the amount of normal tissue that needs to be removed.

      PURPOSE: This phase II trial is studying how well giving panitumumab together with docetaxel,
      cisplatin, radiation therapy, and surgery works in treating patients with newly diagnosed,
      locally advanced esophageal cancer or cancer of the gastroesophageal junction.
    

Eligibility criteria:

        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.