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Bevacizumab

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Angiogenesis Inhibitors

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Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses.

Avastin

Paul Nguyen, MD

This research study is evaluating a drug called avastin in combination with standard radiation as a possible treatment for treatment for recurrent pelvic-confined gynecological cancer (i.e. endometrial, cervical, vulvar, ovarian or vaginal cancers).

The purpose of this research study is to learn the effects (good and bad) of an antiangiogenic therapy drug (drugs that stop new blood vessel growth and starve a tumor by cutting off its blood supply) called avastin. Avastin is an antibody directed against vascular endothelial growth factor, or VEGF. VEGF is a potent, specific growth factor with a well-defined role in normal and abnormal blood vessel formation. It is present in a wide variety of normal tissues, but is produced in excess by most solid cancers (tumors). In the setting of cancer, VEGF promotes the growth of blood vessels that bring nutrients to tumor cells. In laboratory studies, avastin has been shown to inhibit the growth of several different types of human cancer cells.

This drug has been studied in at least 3500 people with breast, colorectal, renal, ovarian and lung cancer. It has not been studied in combination radiation therapy in people with recurrent gynecological cancer.

Previous clinical trials involving the use of avastin in combination with standard radiation in colorectal and pancreatic cancer show no significant increase in toxicity as compared to standard radiation therapy toxicity.

The primary objective of this study is to assess the toxicity of administering avastin with radiation for recurrent gynecological cancer. The secondary endpoint will be to assess the time to progression of the disease. This means we hope this treatment program will delay any regrowth of your cancer as compared to standard therapy with radiotherapy alone. In addition, how well you respond to the treatment, patterns of remission or recurrence will be measured.

Safety Study Of Avastin And Pelvic Radiation In Women With Recurrent Gynecological Cancers

A Pilot Study Evaluating The Safety Of Avastin And Pelvic Radiation In Women With Pelvic-Confined Recurrence of Gynecological Cancers

Toxicity was the cumulative number of events, all grades and categories, related to side effects from avastin and radiation including, but not limited to, bowel, bladder, skin, gynecologic and other morbidity.

Progression free survival was calculated from the date of diagnosis to the date of disease progression as detected by clinical examination or imaging.

Genentech, Inc.

Brigham and Women's Hospital

Beth Israel Deaconess Medical Center

Massachusetts General Hospital

Lowell General Hospital

Saint Anne's Hospital

Dana-Farber Cancer Institute

Paul Nguyen MD

Avastin and daily radiation

Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses.

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Modified intention to treat (ITT), i.e., include all subjects that received and completed treatment.

Akila N. Viswanathan, MD, MPH

20 patients received and completed treatment.

Toxicity Rates of Patients Treated With Concurrent Avastin and Daily Pelvic Radiation With no Other Concurrent Chemotherapy

Single-arm feasibility study; Kaplan Meier analysis was applied to estimate one-year PFS distribution as well as to calculate proportion of patients remain progression free by month 12.

Single Point Estimate of 1-year Progression-free Survival of Patients Treated With Concurrent Avastin and Daily Pelvic Radiation With no Other Concurrent Chemotherapy

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety Study Of Avastin And Pelvic Radiation In Women With Recurrent Gynecological Cancers	NCT00545792	Cervical Cancer Endometrial Can... Ovarian Cancer Vaginal Cancer Carcinoma of th...	Avastin	18 Years -	Dana-Farber Cancer Institute
Safety Study Of Avastin And Pelvic Radiation In Women With Recurrent Gynecological Cancers	NCT00545792	Cervical Cancer Endometrial Can... Ovarian Cancer Vaginal Cancer Carcinoma of th...	Avastin	18 Years -	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for vaginal recurrence