NCT02884648

Brief Summary

The goal of this clinical research study is to learn if Avastin (bevacizumab) can help to control ovarian, fallopian, or primary peritoneal cancer that has been found during second-look surgery.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
7mo left

Started Nov 2016

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Nov 2016Feb 2027

First Submitted

Initial submission to the registry

August 26, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

November 15, 2016

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2027

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

10.2 years

First QC Date

August 26, 2016

Last Update Submit

February 4, 2026

Conditions

Fallopian Tube CancerPrimary Peritoneal CancerOvarian CancerMalignant Neoplasms of Female Genital Organs

Keywords

Malignant neoplasms of female genital organsOvarian CancerFallopian tube cancerPrimary peritoneal cancerBevacizumabAvastinAnti-VEGF monoclonal antibodyrhuMab-VEGF

Outcome Measures

Primary Outcomes (1)

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

    PFS defined as the interval between the first dose of Bevacizumab and radiographically demonstrated progression by RECIST criteria.

    63 days

Study Arms (1)

Bevacizumab

EXPERIMENTAL

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.

Drug: Bevacizumab

Interventions

BevacizumabDRUG

15 mg/kg by vein on Day 1 of every 21-day study cycle.

Also known as: Avastin, Anti-VEGF Monoclonal Antibody, rhyMab-VEGF
Bevacizumab

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed written Informed Consent (in participant's preferred language or short form, per SOP04).
  • Age\>/= 18 years of age or older.
  • Histologically confirmed Stage III-IV high-grade epithelial non-mucinous ovarian, fallopian tube, or primary peritoneal cancers.
  • Have received standard of care frontline surgical and chemotherapy treatment (at least six cycles of platinum and taxane therapy). Patients who received neoadjuvant therapy are included.
  • 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).
  • Histologically confirmed residual ovarian cancer at time of second-look surgery. Patients with cytological evidence of malignant cells in washings obtained as part of the second look procedure are eligible even if biopsies are negative.
  • Be willing to allow use of archival tissue from second-look surgery and primary surgery or biopsy for use in this study.
  • Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale at the time of screening.
  • 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 adequately recovered from second look surgery to be able to start bevacizumab within 7 weeks of this procedure.
  • Negative serum pregnancy within 72 hours prior to receiving the first dose of study medication (unless surgically sterile or postmenopausal for greater than one year).
  • Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year.

You may not qualify if:

  • Uncontrolled hypertension as defined by SBP\>150 or DBP\>90 on at least two separate occasions documented in the medical record. Patients would be eligible if blood pressure is controlled with appropriate anti-hypertensive therapy. Rescreening after this therapy has been instituted is allowed.
  • Histology showing mucinous or low-grade epithelial ovarian carcinoma.
  • Documented germline or somatic BRCA mutations and/or HRD positivity.
  • Planned use of maintenance or consolidative therapy.
  • History of known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the Study.
  • History of arterial thrombosis. Patients with history of DVT are eligible as long as they have received or are receiving appropriate anticoagulation therapy.
  • History of gastrointestinal or urinary fistulae, non-healed or chronic wound, or other conditions that, in the investigator's view, would contraindicate or significantly increase the risks of bevacizumab therapy.
  • History of known hemoptysis, gastrointestinal or intracerebral hemorrhage.
  • Patient that is not able to understand or to comply with the study instructions and requirements, or has a history of non-compliance to the medical regimen.
  • Concurrent or planned use of any other anti-cancer systemic chemotherapy, biological therapy (including hormonal or immune therapy), radiation therapy, or live cancer vaccines.
  • Prior use of bevacizumab or a biosimilar in the frontline treatment setting.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Ovarian NeoplasmsFallopian Tube Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Amir A. Jazaeri, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2016

First Posted

August 31, 2016

Study Start

November 15, 2016

Primary Completion (Estimated)

February 2, 2027

Study Completion (Estimated)

February 2, 2027

Last Updated

February 6, 2026

Record last verified: 2026-02

Locations

US(1)