Can avastin stop ovarian cancer from coming back?
NCT ID NCT02884648
First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times
Summary
This phase II trial tests whether the drug bevacizumab (Avastin) can help control ovarian, fallopian tube, or primary peritoneal cancer that is still present after initial treatment. About 35 women whose cancer was found during a second-look surgery will receive bevacizumab every three weeks. The main goal is to see how long the cancer stays under control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bevacizumab (Avastin)
- What this could lead to
- If it works, this could offer a way to delay or prevent the return of ovarian cancer after initial treatment.
- What could go wrong
- This is a small, early-phase trial with only 35 participants, so results may not apply widely. Bevacizumab can cause side effects like high blood pressure or bleeding.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2016
- Expected to finish
-
Feb 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Signed written Informed Consent (in participant's preferred language or short form, per SOP04). 2. Age\>/= 18 years of age or older. 3. Histologically confirmed Stage III-IV high-grade epithelial non-mucinous ovarian, fallopian tube, or primary peritoneal cancers. 4. 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. 5. 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). 6. 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. 7. Be willing to allow use of archival tissue from second-look surgery and primary surgery or biopsy for use in this study. 8. Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale at the time of screening. 9. 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. 10. Have adequately recovered from second look surgery to be able to start bevacizumab within 7 weeks of this procedure. 11. 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). 12. 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. Exclusion Criteria: 1. 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. 2. Histology showing mucinous or low-grade epithelial ovarian carcinoma. 3. Documented germline or somatic BRCA mutations and/or HRD positivity. 4. Planned use of maintenance or consolidative therapy. 5. History of known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the Study. 6. History of arterial thrombosis. Patients with history of DVT are eligible as long as they have received or are receiving appropriate anticoagulation therapy. 7. 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. 8. History of known hemoptysis, gastrointestinal or intracerebral hemorrhage. 9. 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. 10. Concurrent or planned use of any other anti-cancer systemic chemotherapy, biological therapy (including hormonal or immune therapy), radiation therapy, or live cancer vaccines. 11. Prior use of bevacizumab or a biosimilar in the frontline treatment setting.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
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