A Randomized Phase III Evaluation of Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF With Bevacizumab (NSC #704865, IND #7921) Versus Docetaxel (NSC #628503) and Gemcitabine (NSC #613327)Plus G-CSF With Placebo in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus
ID Number 05-0982-00250Principal Investigator(s)
Department(s) or Division(s)
The purpose of this study is to compare the treatment of your disease with gemcitabine plus docetaxel to the treatment of your disease with gemcitabine plus docetaxel plus the addition of a third drug, called bevacizumab. We will be looking to see whether adding bevacizumab helps control cancer growth for longer, and whether adding bevacizumab causes more side effects.
You may qualify for participation in this study because you have been diagnosed with uterine cancer, specifically leiomyosarcoma, that is in an advanced stage or that has come back again after initial treatment with surgery and possibly with radiation therapy. Currently, leiomyosarcoma may be treated with a combination of two chemotherapy drugs, which are gemcitabine and docetaxel. These two chemotherapy drugs have already shown to be effective in treating leiomyosarcoma. Bevacizumab (Avastin™) has recently been approved by the U.S. Food and Drug Administration (FDA) for use in combination with chemotherapy in patients with colon cancer, lung cancer, renal cell cancer, or breast cancer that has spread to distant sites in the body. Bevacizumab is the common name for the commercial drug Avastin. However, the bevacizumab used in this study is considered investigational because it is not FDA-approved for use in combination with chemotherapy in patients with uterine leiomyosarcoma.
Recruiting Patients: Yes