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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%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival (PFS)
Secondary outcome measures
Response rate assessed using Response Evaluation Criteria in Solid Tumors
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
~5280
Paclitaxel
2011
Completed Phase 4
~5380
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,057 Total Patients Enrolled
286 Trials studying Ovarian Cancer
73,766 Patients Enrolled for Ovarian Cancer
Stephanie LheureuxPrincipal InvestigatorUniversity Health Network Princess Margaret Cancer Center LAO
5 Previous Clinical Trials
439 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently taking any experimental medications.My eligibility is not based on mesothelin levels for the initial phase.I have serious blood vessel problems in my arms or legs.I do not have an active HIV, hepatitis B, or C infection.I have a confirmed diagnosis of advanced ovarian, fallopian tube, or primary peritoneal cancer.My ovarian cancer did not respond well to platinum-based treatments.I have a serious blood vessel condition like an aortic aneurysm.Your urine protein to creatinine ratio needs to be less than or equal to 1.I have severe allergies to medications similar to bevacizumab, anetumab ravtansine, or paclitaxel.My heart's electrical activity test shows a QT interval longer than 470 msec, or I have a family history of long QT syndrome.You have a condition that makes it hard for your blood to clot or you are prone to bleeding.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I have had paclitaxel or bevacizumab for cancer that got worse within 6 months of platinum chemotherapy.I am not taking any strong medication that affects liver enzymes.Your medical scans show that the disease is getting worse.Your total bilirubin levels are within the normal range, unless you have Gilbert's syndrome.You are allergic to products made from Chinese hamster ovary cells or other genetically engineered human antibodies.Your white blood cell count is at least 1.5 billion per liter.My side effects from previous treatments are mild, except for hair loss, nerve issues, or low lymphocyte count.I am not pregnant or breastfeeding, and if capable of becoming pregnant, I agree to use contraception during and for 6 months after the study.I do not have any major heart problems.I have not had a stroke in the last 6 months.I haven't had major surgery or significant injury recently and don't expect to need major surgery during the study.I have a serious heart rhythm problem that isn't well-controlled.I have not had a bowel obstruction in the last 28 days.I can take care of myself but might not be able to do heavy physical work.I have a tumor that can be measured with scans or physical exam.I have brain metastases but haven't needed steroids or symptoms for 4 weeks.I can understand and am willing to sign the consent form, or I have someone legally authorized to do so for me.My kidney function is within the required range.My tumor is positive for mesothelin based on a specific test.I haven't had chemotherapy or radiotherapy in the last 4 to 6 weeks.I have moderate to severe eye inflammation or damage.I haven't had blood clots, bleeding issues, or non-healing wounds in the last 3 months.Your white blood cell count is equal to or greater than 3 billion per liter.Your liver enzymes (AST and ALT) are not more than 2.5 times the normal level.I have a serious or non-healing wound, ulcer, or bone fracture.You must have at least 100 billion platelets per liter of blood.I have not had a heart attack or unstable chest pain in the last 6 months.I haven't had any major abdominal issues like fistulas, perforations, or abscesses in the last 6 months.My blood pressure is high despite taking medication.
Research Study Groups:
This trial has the following groups:- Group 1: GROUP I (anetumab ravtansine, bevacizumab)
- Group 2: GROUP II (paclitaxel, bevacizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is Anetumab Ravtansine hazardous to human health?
"Anetumab Ravtansine was graded a 2 on our risk scale as it is currently in Phase 2, suggesting that there are some safety data present but no evidence of efficacy."
Answered by AI
What medicinal purpose does Anetumab Ravtansine typically serve?
"Anetumab Ravtansine has been proven to be effective in abating recurrent platinum-sensitive epithelial ovarian cancer, malignant neoplasms, and persistent cervical cancer."
Answered by AI
Could you describe any other research involving Anetumab Ravtansine which has been performed?
"At present, there are 1128 active clinical studies centred around Anetumab Ravtansine with 294 of them being in the final phase. While most trials for this drug occur in Shanghai, 57144 other medical sites across the globe have launched research regarding it."
Answered by AI
In which locations is this examination conducted?
"The recruitment process for this trial is ongoing with 21 various sites. Examples include University of Virginia Cancer Center, Rutgers Cancer Institute of New jersey, and the University of Wisconsin Hospital & Clinics. Additionally, there are 18 other medical centres participating in the study."
Answered by AI
To what extent is this study recruiting participants?
"This clinical investigation is unfortunately no longer seeking participants. The trial was posted on June 29th 2018 and the last entry was made October 22nd 2022. However, there are numerous other studies taking patients with adenocarcinoma - 3132 trials to be exact - as well as 1128 investigations for Anetumab Ravtansine that remain open for recruitment."
Answered by AI
Is the recruitment process for this clinical trial still underway?
"Currently, clinicaltrials.gov does not indicate that this trial is accepting new participants. This medical study was initially posted on June 29th 2018 and last revised October 22nd 2022; however, there are over 4 thousand other trials currently seeking volunteers."
Answered by AI
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