S0414 Cetuximab, Combo Chemo, and RT in Locally Advanced Esophageal Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Intervention: cetuximab; cisplatin; irinotecan hydrochloride; radiation therapy
Intervention description: 400mg/m^2 loading dose, intravenous (IV) over 120 min, day 1 of cycle 1 only. 250mg/m^2 maintenance dose, IV over 60 min, Days 8 & 15 of Cycle 1 and Days 1, 8, and 15 of subsequent cycles.; 30mg/m^2, bolus intravenous (IV), on Days 1 & 8 of each cycle.; 65mg/m^2, intravenous (IV) over 30 min, on Days 1 & 8 of each cycle.; The total dose to the prescription point will be 5,040 cGy given in 28 fractions. The patient will be treated with one fraction per day with all fields treated per day. 180 cGy will be delivered to the isocenter. The dose variation in the planning target volume (PTV) will be +7% and -5% of the prescription point dose.
Intervention MeSH terms: Irinotecan; 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; squamous cell carcinoma of the esophagus; stage III esophageal cancer

Summary:

      RATIONALE: 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. Cetuximab may also stop the growth
      of esophageal cancer by blocking blood flow to the tumor and by blocking some of the enzymes
      needed for cell growth. Drugs used in chemotherapy, such as cisplatin and irinotecan, 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. Giving
      cetuximab together with combination chemotherapy and radiation therapy may kill more tumor
      cells.

      PURPOSE: This phase II trial is studying how well giving cetuximab together with combination
      chemotherapy and radiation therapy works in treating patients with locally advanced
      esophageal cancer that cannot be removed by surgery.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed primary squamous cell carcinoma or adenocarcinoma of the
             thoracic esophagus (≥ 20 cm from the incisors*) or the gastroesophageal junction
             (confined to ≤ 2 cm into the gastric cardia)

               -  Disease confined to the esophagus or peri-esophageal soft tissue

               -  T4, M0 disease

               -  Surgically unresectable disease by esophageal endoscopic ultrasonography OR
                  medically unresectable disease

        NOTE: *Patients with primary disease < 26 cm from the incisors must undergo bronchoscopy
        AND have negative cytology within the past 4 weeks

          -  Measurable or non-measurable disease by x-ray, CT scan and/or MRI, or physical
             examination within the past 4 weeks (for measurable disease) or within the past 6
             weeks (for non-measurable disease)

          -  Tumor specimens available

          -  No recurrent disease

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Zubrod 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count (ANC) ≥ 1,500/mm^3

          -  White Blood Cell (WBC) count ≥ 3,000/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 10.0 g/dL

        Hepatic

          -  Albumin normal

          -  Bilirubin normal

          -  Alkaline phosphatase normal

          -  Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic pyruvic transaminase
             (SGPT) ≤ 2.5 times upper limit of normal

        Renal

          -  Creatinine clearance > 50 mL/min

        Other

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No prior severe reaction to monoclonal antibodies

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer or carcinoma in situ of the cervix

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  No prior chemotherapy for esophageal cancer

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No prior radiotherapy for esophageal cancer

          -  No concurrent intensity modulated radiotherapy

          -  No concurrent cobalt-60

        Surgery

          -  No prior surgical resection or attempted surgical resection of esophageal cancer