Bevacizumab and Anetumab Ravtansine or Paclitaxel in Treating Patients With Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Part of paid clinical trials in Orange, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03587311
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Fallopian Tube Endometrioid Adenocarcinoma
  • Fallopian Tube High Grade Serous Adenocarcinoma
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian High Grade Serous Adenocarcinoma
  • Platinum-Resistant Fallopian Tube Carcinoma
  • Platinum-Resistant Ovarian Carcinoma
  • Platinum-Resistant Primary Peritoneal Carcinoma
  • Primary Peritoneal High Grade Serous Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Anetumab Ravtansine — BIOLOGICAL
    Given IV
  • Bevacizumab — BIOLOGICAL
    Given IV
  • Paclitaxel — DRUG
    Given IV

Study Details

This phase II trial studies the side effects of bevacizumab and anetumab ravtansine or paclitaxel in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that does not respond to treatment (refractory). Bevacizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Anetumab ravtansine is a drug that targets a protein in the body called mesothelin, which can be found in some ovarian, pancreatic and other tumors. Chemotherapy drugs, 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. It is not yet known whether giving bevacizumab and anetumab ravtansine or paclitaxel may work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.

Key Dates

First listed
Jul 16, 2018
Start date
Oct 12, 2018
Status verified
Apr 2026
Primary completion
Oct 21, 2026
Completion
Oct 21, 2026

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GROUP I (anetumab ravtansine, bevacizumab)
    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.
  • Experimental: GROUP II (paclitaxel, bevacizumab)
    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.

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: From the time of treatment start assessed up to 1 year ]

Locations (22)

FacilityCityStateZIPSite coordinators
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
UCHealth University of Colorado HospitalAuroraColorado80045-
UM Sylvester Comprehensive Cancer Center at Coral GablesCoral GablesFlorida33146-
UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield BeachFlorida33442-
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiamiFlorida33136-
UM Sylvester Comprehensive Cancer Center at PlantationPlantationFlorida33324-
Moffitt Cancer CenterTampaFlorida33612-
Northwestern UniversityChicagoIllinois60611-
HaysMedHaysKansas67601-
The University of Kansas Cancer Center - OlatheOlatheKansas66061-
Mercy Hospital PittsburgPittsburgKansas66762-
Salina Regional Health CenterSalinaKansas67401-
University of Kansas Health System Saint Francis CampusTopekaKansas66606-
University of Kansas Hospital-Westwood Cancer CenterWestwoodKansas66205-
Wayne State University/Karmanos Cancer InstituteDetroitMichigan48201-
Weisberg Cancer Treatment CenterFarmington HillsMichigan48334-
Washington University School of MedicineSt LouisMissouri63110-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232-
University of Virginia Cancer CenterCharlottesvilleVirginia22908-
University of Wisconsin Carbone Cancer Center - University HospitalMadisonWisconsin53792-

Find similar trials in Orange, CA

By research site
UC Irvine Health/Chao Family Comprehensive Cancer Center· Orange, CAUCHealth University of Colorado Hospital· Aurora, COUM Sylvester Comprehensive Cancer Center at Coral Gables· Coral Gables, FLUM Sylvester Comprehensive Cancer Center at Deerfield Beach· Deerfield Beach, FLUniversity of Miami Miller School of Medicine-Sylvester Cancer Center· Miami, FLUM Sylvester Comprehensive Cancer Center at Plantation· Plantation, FL

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