Bevacizumab in Ovarian Cancer Patients With Disease at Second-Look Surgery
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|ClinicalTrials.gov Identifier: NCT02884648|
Recruitment Status : Recruiting
First Posted : August 31, 2016
Last Update Posted : May 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasms of Female Genital Organs Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer||Drug: Bevacizumab||Phase 2|
Study Drug Administration:
If you are found to be eligible to take part in the study, you will receive bevacizumab by vein over about 30 minutes on Day 1 of every 21-day study cycle.
Your first study visit will be about 5-7 weeks after your second-look surgery so that you have time to recover. The study doctor will tell you when you will start having study visits.
During all cycles:
- You will have a physical exam.
- Blood (about 3 tablespoons) will be drawn for routine testing. If you can become pregnant and the doctor thinks it is needed, part of this routine blood sample may be used for a pregnancy test.
During Cycle 3 and then every 3 cycles after that (Cycles 6, 9, 12, and so on), you will have an MRI or CT scan.
Length of Treatment:
You may continue to receive bevacizumab for as long as the study doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over after the end-of-treatment visit.
Within about 7 days after your last dose of bevacizumab:
- You will have a physical exam.
- Blood (about 3 tablespoons) will be drawn for routine testing. If you can become pregnant, part of this sample will be used for a pregnancy test.
This is an investigational study. Bevacizumab is FDA approved and commercially available for the treatment of several types of cancer, including ovarian cancer. However, it is considered investigational to use bevacizumab as treatment for cancer found during second-look surgery.
The study doctor will explain how the study drug is designed to work.
Up to 35 participants will be enrolled in this study. All will take part at MD Anderson.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Investigation of Bevacizumab for the Treatment of Second-Look Positive Epithelial Ovarian Cancer|
|Actual Study Start Date :||November 2016|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2020|
Participants receive Bevacizumab by vein on Day 1 of every 21-day study cycle, for as long as study doctor thinks it is in participant's best interest.
15 mg/kg by vein on Day 1 of every 21-day study cycle.
- Progression-Free Survival (PFS) of Participants with Positive Second-Look Findings Treated with Bevacizumab [ Time Frame: 63 days ]PFS defined as the interval between the first dose of Bevacizumab and radiographically demonstrated progression by RECIST criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02884648
|Contact: Amir A. Jazaeri, MD||713-792-7743||AAJazaeri@mdanderson.org|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Amir A. Jazaeri, MD||M.D. Anderson Cancer Center|