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A Phase II Trial of Cetuximab plus Cisplatin and Irinotecan in Patients with Irinotecan- and Cisplatin-Refractory Metastatic Esophageal and Gastric Cancer

[Protocol 06-095]

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Full Title :

PHASE II TRIAL OF CETUXIMAB PLUS CISPLATIN AND IRINOTECAN IN PATIENTS WITH IRINOTECAN AND CISPLATIN-REFRACTORY METASTATIC ESOPHAGEAL AND GASTRIC CANCER

Purpose :

At present, there are very few active chemotherapy drugs to treat metastatic esophageal and gastric cancer, especially in patients whose cancer continues to grow after initial treatment. The purpose of this study is to determine if adding the drug cetuximab (Erbitux^TM, C225) to the chemotherapy drugs irinotecan (CPT-11) and cisplatin can benefit patients with metastatic esophageal or gastric cancer that continues to grow despite prior treatment with irinotecan and cisplatin.

In patients with metastatic colon cancer, cetuximab appeared to result in more tumor shrinkage when it was given with the chemotherapy drug irinotecan, even in patients who had been treated with irinotecan before. Cetuximab given by itself, or in combination with chemotherapy, has been approved by the FDA for patients with metastatic colorectal cancer as well as for those with head and neck cancers.

Eligibility :

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

• Patients must have a confirmed diagnosis of metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or adenocarcinoma of the gastroesophageal junction or stomach that has progressed despite previous treatment with irinotecan and cisplatin.
• Patients may have had up to two prior regimens of chemotherapy. Patients may not have previously received any drugs that target the epidermal growth factor receptor pathway.
• At least 3 weeks must have passed since prior chemotherapy or radiation therapy and entry into the study, and patients must have recovered from any side effects of treatment.
• Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
• Patients must be age 18 or older.

For more information and to see if you are eligible for this study, please contact Dr. David Ilson at 212-639-8306.