 |
|
|
|
 |
A Randomized Phase II Trial of Gemcitabine and Docetaxel with or without Bevacizumab in Leiomyosarcoma, Malignant Fibrous Histiocytoma, and Angiosarcoma
[Protocol 09-015]
- Full Title :
- A RANDOMIZED PHASE II TRIAL OF GEMCITABINE AND DOCETAXEL WITH OR WITHOUT BEVACIZUMAB IN LEIOMYOSARCOMA, MALIGNANT FIBROUS HISTIOCYTOMA AND ANGIOSARCOMA
- Purpose :
Recurrent sarcoma is difficult to treat. Standard chemotherapy drugs can cause side effects, and the duration of benefit is usually short. As a result, new treatments for sarcoma are needed.
The purpose of this study is to assess the safety and effectiveness of adding bevacizumab to standard chemotherapy (gemcitabine and docetaxel) in patients with metastatic or recurrent leiomyosarcoma, malignant fibrous histiocytoma, or angiosarcoma.
Bevacizumab is already approved for treating advanced colorectal, lung, and breast cancers. It works by inhibiting the development of the blood vessels that tumors need to grow and spread. Patients will be randomly assigned to receive gemcitabine and docetaxel with bevacizumab or gemcitabine and docetaxel with a placebo.
- 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 or recurrent leiomyosarcoma, malignant fibrous histiocytoma, or angiosarcoma.
- Patients may not have had more than one prior regimen of chemotherapy for advanced disease.
- At least 3 weeks must have passed since completion of prior chemotherapy and 4 weeks since major surgery and entry into the study, and patients must have recovered from any side effects.
- Patients may not have had prior treatment with gemcitabine, docetaxel, or bevacizumab.
- 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 between the ages of 18 and 75 (inclusive).
For more information about this study and to inquire about eligibility, please contact Dr. David D'Adamo at 212-639-7573.
|
|
|
|
|
