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| ID | Type | Description | Link |
|---|---|---|---|
| Ovarian SPORE | Other Grant/Funding Number | NCI | |
| NCI-2016-01970 | Registry Identifier | NCI-CTRP |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The goal of this clinical research study is to learn if Avastin (bevacizumab) can help to control ovarian, fallopian, or primary peritoneal cancer that has been found during second-look surgery.
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.
Study Visits:
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:
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.
End-of-Treatment Visit:
Within about 7 days after your last dose of bevacizumab:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | 15 mg/kg by vein on Day 1 of every 21-day study cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) of Participants with Positive Second-Look Findings Treated with Bevacizumab | PFS defined as the interval between the first dose of Bevacizumab and radiographically demonstrated progression by RECIST criteria. | 63 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amir A. Jazaeri, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |