Protocol
10-048
Full Title
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 (NCI Supplied Agent: Bevacizumab (NSC #704865),IND #7921) (GOG 250)
Purpose
Leiomyosarcoma, a cancer of the uterus, can be treated with the chemotherapy drugs gemcitabine and docetaxel. The purpose of this Gynecologic Oncology Group study is to compare treatment with gemcitabine plus docetaxel to gemcitabine plus docetaxel with a third drug called bevacizumab in women with advanced or recurrent leiomyosarcoma. Patients will be randomly assigned to receive one treatment combination or the other.
Bevacizumab is not approved for leiomyosarcoma, but is used to treat advanced colorectal, lung, breast, kidney, and brain cancers. It works by blocking vascular endothelial growth factor (VEGF), a protein that promotes the growth of tumor cells and blood vessels in and around tumors.
Investigator
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 advanced or recurrent uterine leiomyosarcoma.
- Patients must have recovered from recent surgery or radiation therapy and may not have had prior chemotherapy for uterine sarcoma.
- Patients must be age 18 or older
For more information and to see if you are eligible for this study, please contact Dr. Martee L. Hensley at 212-639-6902.
Disease(s)
Endometrial and other Uterine Cancers: Leiomyosarcoma
Endometrial and other Uterine Cancers: Uterine Cancer
Leiomyosarcoma
Sarcomas: Leiomyosarcoma
Locations
