Cetuximab, Cisplatin, and Irinotecan in Treating Patients With Metastatic Esophageal Cancer, Gastroesophageal Junction Cancer, or Gastric Cancer That Did Not Respond to Previous Irinotecan and Cisplatin
Condition: Esophageal Cancer; Gastric Cancer
MeSH terms: Stomach Neoplasms; Esophageal Neoplasms
Study type: Interventional
Phase: Phase 2

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 tumor cells by blocking some of the enzymes needed for their 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. Giving cetuximab
      together with cisplatin and irinotecan may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving cetuximab together with cisplatin
      and irinotecan works in treating patients with metastatic esophageal cancer, gastroesophageal
      junction cancer, or gastric cancer that did not respond to previous irinotecan and cisplatin.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the response rate in patients with irinotecan hydrochloride- and
           cisplatin-refractory metastatic esophageal, gastroesophageal junction, or gastric cancer
           treated with cetuximab, cisplatin, and irinotecan hydrochloride.

      Secondary

        -  Determine the median survival of patients treated with this regimen.

        -  Determine the tolerability of this regimen in these patients.

        -  Determine the adverse event profiles in patients treated with this regimen.

        -  Assess epidermal growth factor receptor expression in tumor tissue from patients treated
           with this regimen.

      OUTLINE: This is an open-label, nonrandomized study.

      Patients receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and cisplatin IV over
      30 minutes and irinotecan hydrochloride IV over 30-90 minutes on days 1 and 8. Treatment
      repeats every 21 days in the absence of disease progression or unacceptable toxicity.

      Patients undergo tumor biopsy at baseline to evaluate epidermal growth factor receptor by
      immunohistochemistry.

      After completion of study treatment, patients are followed every 3 months for up to 1 year.
    

Intervention name(s): cetuximab; cisplatin; irinotecan hydrochloride; immunohistochemistry staining method; laboratory biomarker analysis; biopsy
Intervention type(s): Biological; Drug; Drug; Other; Other; Procedure
Intervention MeSH terms: Irinotecan; Cetuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the esophagus; squamous cell carcinoma of the esophagus; recurrent esophageal cancer; recurrent gastric cancer; adenocarcinoma of the stomach; stage IV esophageal cancer; stage IV gastric cancer