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
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.
Drug: irinotecan hydrochloride
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Cetuximab Plus Cisplatin and Irinotecan in Patients With Irinotecan and Cisplatin-Refractory Metastatic Esophageal and Gastric Cancer|
- Complete and partial response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2006|
|Study Completion Date:||September 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Experimental: Cetuximab, Cisplatin, and Irinotecan
Cetuximab will be combined with weekly irinotecan and cisplatin. Patients will receive cetuximab 400 mg/m2 on day 1, week 1. Following this loading dose, patients will receive weekly cetuximab 250 mg/m2 (day 8, 15, 22, etc.) until disease progression or unacceptable toxicity. Patients will continue to receive irinotecan and cisplatin weekly on day 1 and day 8, on an every 21 day cycle. The standard maximum doses are irinotecan 65 mg/m2 and cisplatin 30 mg/m2.
|Biological: cetuximab Drug: cisplatin Drug: irinotecan hydrochloride Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: biopsy|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00397904
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||David H. Ilson, MD, PhD||Memorial Sloan Kettering Cancer Center.|