Chemotherapy, Radiation Therapy, and Cetuximab Followed by Surgery, Docetaxel, and Cetuximab in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Intervention: 5-Fluorouracil; Oxaliplatin; Cetuximab; Docetaxel; Surgery; Radiotherapy
Intervention description: given IV; given IV; given IV; given IV; Patients underwent surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab.; Patients underwent radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33.
Intervention MeSH terms: Docetaxel; Fluorouracil; Oxaliplatin; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the esophagus; chemoradiotherapy; oxaliplatin; cetuximab; docetaxel

Summary:

      RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and docetaxel, work
      in different ways to stop the growth of tumor cells, either by killing the cells or by
      stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.
      Monoclonal antibodies, such as cetuximab, 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. Giving these treatments before surgery may
      make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
      Giving docetaxel and cetuximab after surgery may kill any tumor cells that remain after
      surgery.

      PURPOSE: This phase II trial is studying how well giving chemotherapy and radiation therapy
      together with cetuximab followed by surgery, docetaxel and cetuximab works in treating
      patients with esophageal cancer or gastroesophageal junction cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed adenocarcinoma of the esophagus (> 20 cm below the incisors) or
             gastroesophageal (GE) junction, untreated with chemotherapy, radiation therapy, and
             surgery. Endoscopy with biopsy and dilation was permitted.

          -  Tumor stage T2N0M0, T3N0M0, T1-3N+M0, or T1-3N0-1M1A as determined by imaging studies
             performed no greater than 4 weeks prior to registration, and biopsy, where
             appropriate. Celiac nodal metastasis (M1A disease) was permitted if other eligibility
             criteria were met. Data from endoscopic ultrasound and endoscopy were required for
             staging. The following imaging was required: CT scan with IV contrast and PET or
             PET+CT. If the PET/CT incorporates CT with IV contrast, then a separate CT is not
             required. If laparoscopy or other relevant procedures were performed, the data were to
             be incorporated into stage assignment. Any lesion suspicious for metastasis had to
             have been biopsied to prove eligibility.

          -  Tumor extension into cardia, if present, must have been no more than 2 cm.

          -  Tumors must have been considered surgically resectable (T1-3, not T4).

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1

          -  Granulocytes > 1,000/ mm³

          -  Platelets > 100,000 μL

          -  Creatinine normal or creatinine clearance > 60 mL/min

          -  Total serum bilirubin < 1.5 mg/dL

          -  Fertile patients must use effective contraception

          -  History of a curatively treated malignancy from which the patient has been
             disease-free for ≥ 2 years and has a survival prognosis of > 5 years

        Exclusion Criteria:

          -  Pregnant or breast-feeding.

          -  Prior severe infusion reaction to a monoclonal antibody

          -  prior therapy specifically and directly targeting the epidermal growth factor receptor
             (EGFR) pathway

          -  Hypertension

          -  Uncontrolled diabetes

          -  Intercurrent illness that would likely interfere with protocol therapy or prevent
             surgical resection

          -  Any of the following within the past 6 months:

               -  New York Heart Association class III-IV congestive heart failure

               -  Cerebrovascular accident or transient ischemic attack

               -  Unstable angina or myocardial infarction