Study of Bevacizumab/Doxil in Treatment of Platinum-Resistant/Refractory Ovarian Cancer (CA)
The purpose of this research study is to test the safety, tolerability, and effectiveness of two chemotherapy drugs, pegylated liposomal doxorubicin (Doxil) and bevacizumab (Avastin). How Doxil is metabolized and excreted from the body will also be studied.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Bevacizumab and Doxil in the Treatment of Platinum-Resistant or Refractory Ovarian Cancer|
- Progression Free Survival (PFS) is the primary outcome measure [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Objective responses will be assessed by RECIST criteria, and by CA125 responses as determined by Rustin [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Overall response rate (ORR) will be measured by assessing complete responses (CR) and partial responses (PR) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Clinical benefit will be assessed by adding stable disease (SD) to ORR [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2007|
|Study Completion Date:||August 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Drug: Doxil and Avastin
Avastin is a humanized monoclonal antibody (a type of protein that is normally made by the immune system to help defend the body from infection and cancer). Avastin has been approved for the treatment of colorectal cancer and lung cancer. Avastin is investigational for the treatment of ovarian cancer and has not been approved by the United States Food and Drug Administration (FDA) for this use.
Avastin is thought to work by attaching to a protein called vascular endothelial growth factor (VEGF) to block its action. VEGF plays a role in the formation of both normal and abnormal blood vessels. It is present in normal tissues, but is produced in excess by most solid cancers (tumors). In cancer, VEGF helps blood vessels bring nutrients to tumor cells, allowing the tumor cells to grow. In laboratory studies with human cancer cells grown in animals, Avastin has been shown to prevent or slow the growth of different types of cancer cells by blocking the effects of VEGF.
Doxorubicin is a type of antibiotic that is only used in cancer chemotherapy. It slows or stops the growth of cancer. Doxorubicin has been approved by the FDA to treat cancers of the head, neck, cervix, vagina, testes, prostate, uterus and Ewing's tumor.
|United States, New Mexico|
|University of New Mexico|
|Albuquerque, New Mexico, United States, 87106|
|New Mexico Cancer Care Associates|
|Santa Fe, New Mexico, United States, 87505|
|United States, New York|
|New York University Cancer Institute|
|New York City, New York, United States, 10016|
|Principal Investigator:||Claire F. Verschraegen, M.D.||University of New Mexico|
|Study Director:||Franco Muggia, MD||New York University Cancer Institute|