NCT02884648Active, not recruitingPhase 2
A Phase II Investigation of Bevacizumab for the Treatment of Second-Look Positive Epithelial Ovarian Cancer
M.D. Anderson Cancer Center1 site in 1 country35 target enrollmentStarted: November 15, 2016Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Progression-Free Survival (PFS) of Participants with Positive Second-Look Findings Treated with Bevacizumab
Study Overview
Brief 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.
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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 year.
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.
- •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.
- •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.
Arms & Interventions
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.
Intervention: Bevacizumab (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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