A Study of the Efficacy and Safety of Bevacizumab in Chinese Women With Newly Diagnosed, Previously Untreated Stage III or Stage IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Last updated: June 20, 2024
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

Ovarian Cancer

Peritoneal Cancer

Pelvic Cancer

Treatment

Paclitaxel

Placebo

Bevacizumab

Clinical Study ID

NCT03635489
YO40268
  • Ages > 18
  • Female

Study Summary

This multicenter, double-blind, 2-arm, randomized study will evaluate the efficacy and safety of bevacizumab plus paclitaxel and caboplatin compared with placebo plus paclitaxel and caboplatin in Chinese participants with newly diagnosed, previously untreated Stage III or Stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer. Participants whose disease has not progressed after six cycles of paclitaxel and carboplatin with either bevacizumab or placebo will continue treatment with either bevacizumab or placebo until disease progression, unacceptable toxicity, or a maximum of 22 cycles, whichever occurs first.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants receiving a histologic diagnosis of epithelial ovarian cancer (EOC),peritoneal primary carcinoma, or fallopian tube cancer.

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

  • Life expectancy of at least 12 weeks.

  • Adequate hematological, liver, renal and neurologic functions.

  • For participants who receive therapeutic anticoagulation: stable anticoagulantregimen.

  • Enrollment between 1 and 12 weeks after initial surgery is performed for thecombined purpose of diagnosis, staging, and cytoreduction

Exclusion

Exclusion Criteria:

  • Current diagnosis of borderline epithelial ovarian tumor or recurrent invasiveepithelial ovarian, primary peritoneal, or fallopian tube cancer treated withsurgery only.

  • Prior radiotherapy to any portion of the abdominal cavity or pelvis.

  • Prior chemotherapy for any abdominal or pelvic tumor, including neoadjuvantchemotherapy for ovarian, primary peritoneal, or fallopian tube cancer.

  • Any prior targeted therapy (including, but not limited to, vaccines, antibodies, ortyrosine kinase inhibitors) or hormonal therapy for management of their epithelialovarian or peritoneal primary cancer.

  • Synchronous primary endometrial cancer.

  • Have a prior history of primary endometrial cancer, except: Stage not greater thanStage IB; no more than superficial myometrial invasion, without vascular orlymphatic invasion; no poorly differentiated subtypes, including papillary serous,clear cell, or other International Federation of Gynecological Oncologists (FIGO)Grade 3 lesions.

  • Cancer present within the last 5 years with the exception of non-melanoma-relatedskin cancers and other specific malignancies or whose previous cancer treatmentcontraindicates study treatment.

  • Active hepatitis B virus (HBV) infection (chronic or acute) or active hepatitis Cvirus (HCV) infection.

  • Serious non-healing wounds, ulcers, or bone fractures.

  • Patients with clinically significant cardiovascular disease.

  • Have known hypersensitivity to Chinese hamster ovary cell products or otherrecombinant human or humanized antibodies.

  • Have known sensitivity to any component of paclitaxel.

  • Undergo major surgical procedure within 28 days prior to randomization oranticipated during the course of the study.

  • Have core biopsy or other minor surgical procedures within 7 days prior to the firstdose of bevacizumab/placebo.

  • History or evidence of thrombotic disorders within the last 6 months prior toenrollment.

Study Design

Total Participants: 100
Treatment Group(s): 4
Primary Treatment: Paclitaxel
Phase: 3
Study Start date:
August 15, 2018
Estimated Completion Date:
May 11, 2023

Connect with a study center

  • Beijing Obstetrics and Gynecology Hospital, Capital Medical University

    Beijing City, 100006
    China

    Site Not Available

  • Jilin Cancer Hospital

    Changchun, 132013
    China

    Site Not Available

  • the First Hospital of Jilin University

    Changchun, 130021
    China

    Site Not Available

  • Xiangya Hospital of Centre-South University

    Changsha, 410008
    China

    Site Not Available

  • Xiangya Hospital Central South University

    Changsha City, 410008
    China

    Site Not Available

  • West China Second University Hospital

    Chengdu City, 610066
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou, 350014
    China

    Site Not Available

  • Sun Yet-sen University Cancer Center

    Guangzhou, 510060
    China

    Site Not Available

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, 510080
    China

    Site Not Available

  • Sun Yet-sen University Cancer Center

    Guangzhou City, 510663
    China

    Site Not Available

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou City, 510080
    China

    Site Not Available

  • Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department

    Hangzhou, 310022
    China

    Site Not Available

  • Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department

    Hangzhou City, 310022
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin, 150081
    China

    Site Not Available

  • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

    Nanjing, 210029
    China

    Site Not Available

  • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

    Nanjing City, 210008
    China

    Site Not Available

  • Guangxi Cancer Hospital of Guangxi Medical University

    Nanning, 530021
    China

    Site Not Available

  • Guangxi Cancer Hospital of Guangxi Medical University

    Nanning City, 530021
    China

    Site Not Available

  • Nan Tong Tumor Hospital

    Nantong,
    China

    Site Not Available

  • Nantong Tumor Hospital

    Nantong City, 226361
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai City, 200120
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, 300052
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin (天津), 300052
    China

    Site Not Available

  • Tianjin Central Hospital of Gynecology Obstetrics.

    Tianjin City, 300052
    China

    Site Not Available

  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University

    Xi'an, 710061
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, 450008
    China

    Site Not Available

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