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A Multicenter Phase II Study of Irinotecan and Alvocidib (Flavopiridol)
versus Irinotecan Alone for Patients with p53 Wild-Type Gastric Adenocarcinoma Whose Disease Has Progressed on One Line of Treatment
[Protocol 09-074]
- Full Title :
- A MULTICENTER RANDOM ASSIGNMENT PHASE II STUDY OF IRINOTECAN AND ALVOCIDIB (FLAVOPIRIDOL) VERSUS IRINOTECAN ALONE FOR PATIENTS WITH P53 WILD TYPE GASTRIC ADENOCARCINOMA (NCI #8060)
- Purpose :
Irinotecan is a standard chemotherapy drug used to treat cancer of the stomach and gastroesophageal junction. The purpose of this study is to evaluate the safety and effectiveness of adding the investigational drug flavopiridol to irinotecan treatment in patients with gastric or gastroesophageal cancer that persists despite prior treatment.
Flavopiridol has been shown in laboratory studies to make chemotherapy such as irinotecan work better. This combination treatment might also be more effective in patients who have cancer cells with a normal form of a protein called p53. Researchers want to assess the combination of irinotecan and flavopiridol in patients with the normal form of the p53 protein.
Patients in this study will be randomly assigned to receive irinotecan alone or in combination with flavopiridol.
- 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 adenocarcinoma of the stomach or gastroesophageal junction that persists despite at least one regimen of chemotherapy and cannot be surgically removed.
- At least 2 weeks must have passed since completion of prior chemotherapy and entry into the study.
- Patients may not have previously received irinotecan or flavopiridol.
- Patients' tumors must contain the normal form of the p53 protein.
- 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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