Bevacizumab in Ovarian Cancer Patients With Disease at Second-Look Surgery (NCT02884648) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Bevacizumab in Ovarian Cancer Patients With Disease at Second-Look Surgery
United States35 participantsStarted 2016-11-15
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. 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.
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Progression-Free Survival (PFS) of Participants with Positive Second-Look Findings Treated with Bevacizumab
✕. 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.
✕. 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.