Paclitaxel, Cisplatin, Gefitinib, and Radiation Therapy Followed by Surgery and Gefitinib in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction That Can Be Removed By Surgery
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Intervention: cisplatin; gefitinib; paclitaxel; adjuvant therapy; radiation therapy
Intervention description: Cisplatin IV; Gefitinib IV; Paclitaxel IV; Postoperative ZD1839; Radiotherapy
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Cisplatin; Gefitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the esophagus; stage II esophageal cancer; stage III esophageal cancer; stage IV esophageal cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed
      for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving these
      treatments before surgery may make the tumor smaller and reduce the amount of normal tissue
      that needs to be removed. Giving gefitinib after surgery may kill any tumor cells that remain
      after surgery.

      PURPOSE: This phase II trial is studying how well giving paclitaxel, cisplatin, gefitinib,
      and radiation therapy followed by surgery and gefitinib works in treating patients with
      locally advanced cancer of the esophagus or gastroesophageal junction that can be removed by
      surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction
             meeting the following criteria:

               -  Newly diagnosed disease

               -  Surgically resectable tumor

               -  Primary esophageal tumor < 20 cm below the incisors

               -  Tumor extending ≤ 2 cm into the cardia

          -  Stage T2-3, N0-1, M0-1a tumor, as determined by imaging studies and biopsy

               -  Documentation by endoscopic ultrasound, endoscopy, and CT scan of the chest and
                  abdomen required

               -  Any lesion suspicious for metastasis must be biopsied

               -  M1a disease (i.e., celiac nodal metastasis) is allowed if other eligibility
                  criteria are met

               -  T4 disease (i.e., involvement of the pleura, pericardium, or diaphragm) allowed
                  provided it is considered resectable

          -  No CNS metastasis

          -  ECOG performance status 0-1

          -  Granulocyte count > 1,000/mm³

          -  Platelet count > 75,000/mm³

          -  Creatinine clearance > 60 mL/min

          -  Total bilirubin < 1.5 mg/dL

          -  No concurrent illness likely to preclude protocol therapy or surgical resection

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after
             completion of study therapy Exclusion Criteria

          -  Known severe hypersensitivity to gefitinib or any of its excipients

          -  Evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated
             respiratory, cardiac, hepatic, or renal disease)

          -  Evidence of other significant clinical disorder or laboratory finding that would
             preclude study participation

          -  Evidence of clinically active interstitial lung disease

          -  Chronic, stable radiographic changes that are asymptomatic are eligible

          -  Prior or concurrent malignancy except basal cell or squamous cell skin cancer,
             cervical cancer, or any other curatively treated malignancy from which the patient has
             been disease-free and has a survival prognosis of > 5 years

          -  Preexisting peripheral neuropathy > grade 1

          -  Incomplete healing from prior oncologic or other major surgery

          -  Prior chemotherapy, radiotherapy, or surgery for this cancer

          -  More than 30 days since prior nonapproved or investigational drugs

          -  Concurrent phenytoin, carbamazepine, barbiturates, rifampin, phenobarbital, or
             Hypericum perforatum (St. John's wort)

          -  Concurrent oral retinoids