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Monoclonal Antibodies

Bevacizumab for Ovarian Cancer

Phase 2

Recruiting

Led By Amir A. Jazaeri, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 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)

Must not have

Documented germline or somatic BRCA mutations and/or HRD positivity

Histology showing mucinous or low-grade epithelial ovarian carcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 63 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if Avastin can help to control ovarian, fallopian, or primary peritoneal cancer after it has been found during second-look surgery.

Who is the study for?

This trial is for women aged 18 or older with Stage III-IV high-grade epithelial non-mucinous ovarian, fallopian tube, or primary peritoneal cancers. They must have completed standard frontline treatment and surgery, be recovered from second-look surgery, not pregnant, and willing to use birth control. Exclusions include a history of certain bleeding disorders, uncontrolled hypertension, prior bevacizumab use in the frontline setting, and specific genetic mutations.

What is being tested?

The study tests if Bevacizumab (Avastin) can control ovarian cancer found during second-look surgery after patients achieved a complete clinical response to initial treatment. It examines the effectiveness of Bevacizumab on those who've had standard chemotherapy and are showing signs of residual cancer at this stage.

What are the potential side effects?

Bevacizumab may cause side effects such as high blood pressure; bleeding issues including nosebleeds; wounds that don't heal properly; gastrointestinal perforations; kidney problems leading to protein loss in urine; infusion reactions like fever or chills; fatigue; low white blood cell counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood counts and kidney, liver functions are within required ranges.

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I've had a follow-up surgery after successful initial cancer treatment and my tests show no signs of cancer.

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I have advanced ovarian, fallopian tube, or peritoneal cancer.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has BRCA mutations or is HRD positive.

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My ovarian cancer is either mucinous or low-grade.

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I have previously been treated with bevacizumab or its equivalent.

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I am not using, nor do I plan to use, any other cancer treatments besides the trial.

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I have had bleeding in my lungs, stomach, or brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 63 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~63 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 63 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-Free Survival (PFS) of Participants with Positive Second-Look Findings Treated with Bevacizumab

Side effects data

From 2015 Phase 4 trial • 45 Patients • NCT02036424

22%

vitreous hemorrhage

17%

worsening of cataract

posterior capsule opacification

vitreous syneresis

cranial nerve VI palsy

pneumonia

pyelonephritis

colon cancer

bradycardia

100%

80%

60%

40%

20%

Study treatment Arm

Bevacizumab

Ozurdex

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: BevacizumabExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

2013

Completed Phase 4

~5540

0 / 9Eligibility criteria met