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A Phase II Study of FOLFOX with and without CT-011 in Patients with Colorectal Cancer Previously Untreated for Metastatic Disease
[Protocol 09-022]
- Full Title :
- PHASE II STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND EFFICACY OF FOLFOX + CT-011 VERSUS FOLFOX ALONE ADMINISTERED INTRAVENOUSLY TO PATIENTS WITH COLORECTAL ADENOCARCINOMA PREVIOUSLY UNTREATED FOR METASTATIC DISEASE
- Purpose :
FOLFOX (a combination of the drugs 5-fluorouracil, leucovorin, and oxaliplatin) is a standard chemotherapy regimen for colorectal cancer. The purpose of this study is to determine if adding an investigational drug called CT-011 to FOLFOX therapy is more effective than FOLFOX alone in patients with metastatic colorectal cancer.
CT-011 is a monoclonal antibody. Monoclonal antibodies are proteins made by the immune system. In previous studies, CT-011 appeared to enhance the killing of tumor cells by the body's immune cells. In this study, patients will be randomly assigned to receive FOLFOX plus CT-011 or FOLFOX alone.
- 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 colorectal cancer.
- Patients may not have previously received chemotherapy for metastatic disease. If patients received prior chemotherapy for nonmetastatic disease, at least 12 months must have passed since completion of treatment and entry into the study.
- At least 4 weeks must have passed since major surgery or radiation therapy and entry into the study.
- 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 about this study and to inquire about eligibility, please contact Dr. Neil H. Segal at 212-639-6237.
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