Malignant Neoplasms of Female Genital OrgansPhase 2NCT02884648
Bevacizumab in Ovarian Cancer Patients With Disease at Second-Look Surgery
A Phase 2 study testing Bevacizumab in people with Malignant Neoplasms of Female Genital Organs and Ovarian Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Malignant Neoplasms of Female Genital Organs, Ovarian Cancer, Fallopian Tube Cancer
- What is being tested?
- Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2016to 2 Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written Informed Consent (in participant's preferred language or short form, per SOP04).
- Age>/= 18 years of age or older.
- Histologically confirmed Stage III-IV high-grade epithelial non-mucinous ovarian, fallopian tube, or primary peritoneal cancers.
- Have received standard of care frontline surgical and chemotherapy treatment (at least six cycles of platinum and taxane therapy). Patients who received neoadjuvant therapy are included.
- Have undergone a second-look surgery by an MD Anderson Gynecologic Oncology faculty after having achieved a complete clinical response to frontline surgery and adjuvant chemotherapy as evidenced by (a) normal physical exam, (b) normal CT or positron emission computed tomography (PET)-CT of abdomen and pelvis or other equivalent imaging, and (c) normalization of CA125 (<35 U/mL).
- Histologically confirmed residual ovarian cancer at time of second-look surgery. Patients with cytological evidence of malignant cells in washings obtained as part of the second look procedure are eligible even if biopsies are negative.
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- Be willing to allow use of archival tissue from second-look surgery and primary surgery or biopsy for use in this study.
- Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale at the time of screening.
- Have adequate organ function as determined by the following laboratory values: a) absolute neutrophil count (ANC) >/= 1,000 /mcL; b) Platelets >/= 100,000/mcL; (c) Hgb >/= 8 g/dL; (d) Creatinine Clearance >/= 40 mL/min (measured or calculated per local practice); (e) Total Bilirubin </= 1.5 × upper limit of normal (ULN) or </= 3 × ULN in the case of suspected/documented Gilbert's Syndrome; and (f) AST (SGOT) and ALT (SGPT) </= 2.5 X ULN.
- Have adequately recovered from second look surgery to be able to start bevacizumab within 7 weeks of this procedure.
- Negative serum pregnancy within 72 hours prior to receiving the first dose of study medication (unless surgically sterile or postmenopausal for greater than one year).
- Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
Who cannot join
- Uncontrolled hypertension as defined by SBP>150 or DBP>90 on at least two separate occasions documented in the medical record. Patients would be eligible if blood pressure is controlled with appropriate anti-hypertensive therapy. Rescreening after this therapy has been instituted is allowed.
- Histology showing mucinous or low-grade epithelial ovarian carcinoma.
- Documented germline or somatic BRCA mutations and/or HRD positivity.
- Planned use of maintenance or consolidative therapy.
- History of known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the Study.
- History of arterial thrombosis. Patients with history of DVT are eligible as long as they have received or are receiving appropriate anticoagulation therapy.
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- History of gastrointestinal or urinary fistulae, non-healed or chronic wound, or other conditions that, in the investigator's view, would contraindicate or significantly increase the risks of bevacizumab therapy.
- History of known hemoptysis, gastrointestinal or intracerebral hemorrhage.
- Patient that is not able to understand or to comply with the study instructions and requirements, or has a history of non-compliance to the medical regimen.
- Concurrent or planned use of any other anti-cancer systemic chemotherapy, biological therapy (including hormonal or immune therapy), radiation therapy, or live cancer vaccines.
- Prior use of bevacizumab or a biosimilar in the frontline treatment setting.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase II Investigation of Bevacizumab for the Treatment of Second-Look Positive Epithelial Ovarian Cancer
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.
Read the detailed description
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:
- 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.
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.
- Conditions
- Malignant Neoplasms of Female Genital Organs, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- Being tested
- Bevacizumab
- Keywords
- Malignant neoplasms of female genital organs, Ovarian Cancer, Fallopian tube cancer, Primary peritoneal cancer, Bevacizumab, Avastin, Anti-VEGF monoclonal antibody, rhuMab-VEGF
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin, Anti-VEGF Monoclonal Antibody, rhyMab-VEGF
15 mg/kg by vein on Day 1 of every 21-day study cycle.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 63 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study start15 Nov 2016
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasms of Female Genital OrgansStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Amir A. Jazaeri, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884648
- Sponsor's protocol ID
- 2015-0520
- Other IDs
- Ovarian SPORE, NCI-2016-01970
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2016
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Investigation of Bevacizumab for the Treatment of Second-Look Positive Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT02884648
- Acronym / sponsor ID
- 2015-0520
- Conditions
- Malignant Neoplasms of Female Genital Organs, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- Keywords
- Malignant neoplasms of female genital organs, Ovarian Cancer, Fallopian tube cancer, Primary peritoneal cancer, Bevacizumab, Avastin, Anti-VEGF monoclonal antibody, rhuMab-VEGF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 31 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab | Experimental | Drug: BevacizumabParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed written Informed Consent (in participant's preferred language or short form, per SOP04).
- Age>/= 18 years of age or older.
- Histologically confirmed Stage III-IV high-grade epithelial non-mucinous ovarian, fallopian tube, or primary peritoneal cancers.
- Have received standard of care frontline surgical and chemotherapy treatment (at least six cycles of platinum and taxane therapy). Patients who received neoadjuvant therapy are included.
- Have undergone a second-look surgery by an MD Anderson Gynecologic Oncology faculty after having achieved a complete clinical response to frontline surgery and adjuvant chemotherapy as evidenced by (a) normal physical exam, (b) normal CT or positron emission computed tomography (PET)-CT of abdomen and pelvis or other equivalent imaging, and (c) normalization of CA125 (<35 U/mL).
Key exclusion criteria (11 listed)
- Uncontrolled hypertension as defined by SBP>150 or DBP>90 on at least two separate occasions documented in the medical record. Patients would be eligible if blood pressure is controlled with appropriate anti-hypertensive therapy. Rescreening after this therapy has been instituted is allowed.
- Histology showing mucinous or low-grade epithelial ovarian carcinoma.
- Documented germline or somatic BRCA mutations and/or HRD positivity.
- Planned use of maintenance or consolidative therapy.
- History of known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the Study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabAlso: Avastin, Anti-VEGF Monoclonal Antibody, rhyMab-VEGF15 mg/kg by vein on Day 1 of every 21-day study cycle. | Drug | Bevacizumab |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir A. Jazaeri, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab in people with Malignant Neoplasms of Female Genital Organs and Ovarian Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) of Participants with Positive Second-Look Findings Treated with Bevacizumab (time frame: 63 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.