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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00397904 |
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.
Condition | Intervention | Phase |
Esophageal Cancer Gastric Cancer |
Drug: cetuximab Drug: cisplatin Drug: irinotecan hydrochloride Procedure: biopsy Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis |
Phase II |
MedlinePlus related topics: | Cancer Esophageal Cancer Esophagus Disorders Stomach Cancer |
Drug Information available for: | Cisplatin Irinotecan Irinotecan hydrochloride Cetuximab |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | Phase II Trial of Cetuximab Plus Cisplatin and Irinotecan in Patients With Irinotecan and Cisplatin-Refractory Metastatic Esophageal and Gastric Cancer |
Estimated Enrollment: | 25 |
Study Start Date: | October 2006 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed diagnosis of 1 of the following:
Failed prior treatment with cisplatin and irinotecan hydrochloride, defined by the following:
Pathologic tissue available for immunohistochemistry (IHC) staining for the epidermal growth factor receptor (EGFR)
PATIENT CHARACTERISTICS:
No uncontrolled illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
No prior anticancer murine or chimeric monoclonal antibody therapy
United States, New York | |||||
Memorial Sloan-Kettering Cancer Center | Recruiting | ||||
New York, New York, United States, 10021 | |||||
Contact: David H. Ilson, MD, PhD 212-639-8306 |
Memorial Sloan-Kettering Cancer Center |
National Cancer Institute (NCI) |
Principal Investigator: | David H. Ilson, MD, PhD | Memorial Sloan-Kettering Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000513214, MSKCC-06095 |
First Received: | November 9, 2006 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00397904 |
Health Authority: | Unspecified |
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