TerminatedPhase 2

Paclitaxel and Bevacizumab With or Without Emactuzumab in Treating Patients With Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Stopped: The study was terminated early by the Sponsor

United States9 participantsStarted 2017-05-05

Plain-language summary

This randomized phase II trial studies the side effects of paclitaxel and bevacizumab with or without emactuzumab and how well they work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back after treatment with platinum chemotherapy. Monoclonal antibodies, such as emactuzumab, block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab may prevent the growth of new blood vessels that tumors need to grow. Giving emactuzumab with paclitaxel and bevacizumab may work better in treating ovarian, fallopian tube, or primary peritoneal cancer.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the study requirements (inclusive of 2 biopsies, one at baseline and if they qualify, one pre-randomization for part 2B) * Women 18 years of age or older * Histologically confirmed and documented disease to include: adenocarcinoma NOS (not otherwise specified), clear cell adenocarcinoma, endometrioid adenocarcinoma, malignant Brenner's tumor, mixed epithelial carcinoma, mucinous adenocarcinoma, serous adenocarcinoma, transitional cell carcinoma, and undifferentiated carcinoma * Patients must have platinum-resistant disease, (defined as progression within \< 6 months from completion of a minimum of 4 platinum therapy cycles (+ 7 days); the date should be calculated from the last administered dose of platinum therapy) * Patients must have disease that is measurable according to RECIST 1.1 or assessable according to the GCIG CA-125 criteria and require chemotherapy treatment; part 1: patients must have one or more measurable target lesion; part 2: patients must have two or more measurable target lesions; measurable disease is defined at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each 'target' lesion must be \>= 20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), a…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part 1: To Evaluate the Safety of Administration of Paclitaxel, Bevacizumab and Emactuzumab Over 4 Weeks.

Timeframe: Up to 4 weeks

Part 2B: To Compare the Progression-free Survival (PFS) of Patients With Stable Disease Following Part 2A Randomized to Paclitaxel Plus Bevacizumab or to Paclitaxel, Bevacizumab Plus Emactuzumab.

Timeframe: At 32 weeks

Trial details

NCT IDNCT02923739

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-27

Results submitted2023-08-17

View on ClinicalTrials.gov More Fallopian Tube Adenocarcinoma trials