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A Phase II Study of Pre-Operative Chemotherapy Plus Bevacizumab with Early Salvage Therapy in Patients with Locally Advanced Resectable Gastric and Gastroesophageal Junction Adenocarcinoma
[Protocol 08-081]
- Full Title :
- A PHASE II STUDY OF PRE-OPERATIVE CHEMOTHERAPY PLUS BEVACIZUMAB WITH EARLY SALVAGE THERAPY BASED ON PET ASSESSMENT OF RESPONSE IN PATIENTS WITH LOCALLY ADVANCED BUT RESECTABLE GASTRIC AND GEJ ADENOCARCINOMA
- Purpose :
Patients with localized stomach and gastroesophageal junction (GEJ) cancers receive chemotherapy before surgery to improve the chance of survival. Chemotherapy can reduce the size of the cancer and make the operation easier. Chemotherapy can also fight small areas of cancer that may reside elsewhere in the body. The standard chemotherapy that is given before surgery is a combination of three drugs: epirubicin, cisplatin, and capecitabine.
In this study, the use of PET scans to help direct preoperative treatment in this disease is being evaluated. Patients with previously untreated localized stomach and GEJ cancers who have a positive PET scan at baseline will receive these three drugs along with bevacizumab, a drug approved for the treatment of advanced breast, lung, and colorectal cancers which is also being assessed for the treatment of other tumors.
After the first cycle of treatment, patients will have a second PET scan to see how the tumor is responding to therapy. Those whose tumors are shrinking will continue receiving the four-drug treatment; those whose tumors are not responding will instead receive docetaxel and irinotecan (standard chemotherapy drugs used to treat cancers of the stomach and GEJ) as well as bevacizumab.
- 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 locally advanced adenocarcinoma of the stomach or gastroesophageal junction that can be surgically removed.
- Patients must have FDG-avid disease (confirmed on a PET scan performed at Memorial Hospital).
- Patients may not have previously received radiation therapy or chemotherapy for their cancer.
- At least 4 weeks must have passed since any major surgery and entry into the study.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. Manish Shah at 212-639-3113.
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