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Monoclonal Antibodies

Bevacizumab + Anetumab Ravtansine/Paclitaxel for Ovarian Cancer

Phase 2

Waitlist Available

Led By Stephanie Lheureux

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patients must have histologically or cytologically confirmed high grade serous or high grade endometrioid ovarian, fallopian tube, primary peritoneal cancer

Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

Must not have

Clinically significant peripheral vascular disease

Known active human immunodeficiency virus (HIV) or hepatitis B or C infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing bevacizumab and anetumab ravtansine or paclitaxel to treat ovarian, fallopian tube, or primary peritoneal cancer that has not responded to treatment.

Who is the study for?

This trial is for patients with certain types of ovarian, fallopian tube, or primary peritoneal cancer that have not responded to platinum-based chemotherapy. Participants must have measurable disease progression and be in good enough health to perform daily activities (ECOG <=2). They should not have had recent major surgeries or other treatments and must agree to use contraception if applicable.

What is being tested?

The study compares the effectiveness of Bevacizumab combined with Anetumab Ravtansine versus Paclitaxel alone in treating refractory cancers. Bevacizumab targets tumor blood supply, Anetumab Ravtansine attacks a specific protein on cancer cells, while Paclitaxel interferes with cell division.

What are the potential side effects?

Possible side effects include allergic reactions similar to those from compounds related to the drugs being tested. There may also be risks of bleeding, high blood pressure, wound healing complications, organ inflammation due to immune responses, and general symptoms like fatigue.

Eligibility Criteria

Inclusion Criteria

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

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I have a confirmed diagnosis of advanced ovarian, fallopian tube, or primary peritoneal cancer.

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I can take care of myself but might not be able to do heavy physical work.

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My kidney function is within the required range.

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I have a tumor that can be measured with scans or physical exam.

Exclusion Criteria

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

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I have serious blood vessel problems in my arms or legs.

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I do not have an active HIV, hepatitis B, or C infection.

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I have a serious blood vessel condition like an aortic aneurysm.

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I have severe allergies to medications similar to bevacizumab, anetumab ravtansine, or paclitaxel.

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My heart's electrical activity test shows a QT interval longer than 470 msec, or I have a family history of long QT syndrome.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I have had paclitaxel or bevacizumab for cancer that got worse within 6 months of platinum chemotherapy.

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I do not have any major heart problems.

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I have not had a stroke in the last 6 months.

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I have a serious heart rhythm problem that isn't well-controlled.

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I have not had a bowel obstruction in the last 28 days.

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I have moderate to severe eye inflammation or damage.

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I have a serious or non-healing wound, ulcer, or bone fracture.

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I haven't had any major abdominal issues like fistulas, perforations, or abscesses in the last 6 months.

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My blood pressure is high despite taking medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year 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)

Secondary study objectives

Response rate assessed using Response Evaluation Criteria in Solid Tumors

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: GROUP II (paclitaxel, bevacizumab)Experimental Treatment2 Interventions

Patients receive paclitaxel on days 1, 8, 15, and 22 and bevacizumab over 30-90 minutes IV on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: GROUP I (anetumab ravtansine, bevacizumab)Experimental Treatment2 Interventions

Patients receive anetumab ravtansine IV over 1 hour on days 1, 8, 15, and 22 and bevacizumab over 30-90 minutes IV on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

2013

Completed Phase 4

~5540

Paclitaxel

2011

Completed Phase 4

~5370