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
A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo Versus Carboplatin Paclitaxel Plus Concurrent and Extended Bevacizumab in Chinese Women With Newly Diagnosed, Previously Untreated, Stage III or Stage IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
1 other identifier
interventional
100
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 ovarian-cancer
Started Aug 2018
16 active sites
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
First Submitted
Initial submission to the registry
August 14, 2018
CompletedStudy Start
First participant enrolled
August 15, 2018
CompletedFirst Posted
Study publicly available on registry
August 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2021
CompletedResults Posted
Study results publicly available
March 17, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 11, 2023
CompletedOctober 3, 2024
June 1, 2024
2.8 years
August 14, 2018
May 26, 2022
June 20, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS)
PFS was defined as time from randomization to the first occurrence of disease progression, as assessed by the Investigator using RECIST v1.1, or death from any cause, whichever occurs first.
Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 24 months)
Secondary Outcomes (11)
Overall Survival (OS)
Randomization up to to death from any cause (up to approximately 54.1 months)
Objective Response Rate (ORR)
Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 24 months)
Duration of Response (DOR)
From the date of first occurrence of a complete or partial response until disease progression or death from any cause (up to approximately 24 months)
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Abdominal Pain
From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Bloating
From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)
- +6 more secondary outcomes
Study Arms (2)
Bevacizumab + Paclitaxel + Carboplatin
EXPERIMENTALParticipants will receive paclitaxel, carboplatin intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Bevacizumab IV infusion will start at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurs first.
Placebo + Paclitaxel + Carboplatin
PLACEBO COMPARATORParticipants will receive paclitaxel, carboplatin IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Placebo IV infusion will start at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurs first.
Interventions
175 mg/m\^2 IV infusion on Day 1 of each 21-day cycle.
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Area Under the Curve (AUC) of 6 mg/ml/min on Day 1 of each 21-day cycle.
Placebo matched to bevacizumab IV infusion on Day 1 of each 21-day cycle.
Eligibility Criteria
You may qualify if:
- 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 anticoagulant regimen.
- Enrollment between 1 and 12 weeks after initial surgery is performed for the combined purpose of diagnosis, staging, and cytoreduction
You may not qualify if:
- Current diagnosis of borderline epithelial ovarian tumor or recurrent invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer treated with surgery only.
- Prior radiotherapy to any portion of the abdominal cavity or pelvis.
- Prior chemotherapy for any abdominal or pelvic tumor, including neoadjuvant chemotherapy for ovarian, primary peritoneal, or fallopian tube cancer.
- Any prior targeted therapy (including, but not limited to, vaccines, antibodies, or tyrosine kinase inhibitors) or hormonal therapy for management of their epithelial ovarian or peritoneal primary cancer.
- Synchronous primary endometrial cancer.
- Have a prior history of primary endometrial cancer, except: Stage not greater than Stage IB; no more than superficial myometrial invasion, without vascular or lymphatic 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-related skin cancers and other specific malignancies or whose previous cancer treatment contraindicates study treatment.
- Active hepatitis B virus (HBV) infection (chronic or acute) or active hepatitis C virus (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 other recombinant human or humanized antibodies.
- Have known sensitivity to any component of paclitaxel.
- Undergo major surgical procedure within 28 days prior to randomization or anticipated during the course of the study.
- Have core biopsy or other minor surgical procedures within 7 days prior to the first dose of bevacizumab/placebo.
- History or evidence of thrombotic disorders within the last 6 months prior to enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Beijing, 100006, China
the First Hospital of Jilin University
Changchun, 130021, China
Jilin Cancer Hospital
Changchun, 132013, China
Xiangya Hospital Central South University
Changsha, 410008, China
West China Second University Hospital
Chengdu, 610066, China
Fujian Cancer Hospital
Fuzhou, 350014, China
Sun Yet-sen University Cancer Center
Guangzhou, 510663, China
Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department
Hangzhou, 310022, China
Harbin Medical University Cancer Hospital
Harbin, 150081, China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, 210008, China
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, 530021, China
Nantong Tumor Hospital
Nantong, 226361, China
Fudan University Shanghai Cancer Center
Shanghai, 200120, China
Tianjin Medical University General Hospital
Tianjin, 300052, China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, 710061, China
Henan Cancer Hospital
Zhengzhou, 450008, China
Related Publications (2)
Wu X, Liu J, An R, Yin R, Zhang Y, Zhou H, He A, Wang L, Zhang J, Liu Z, Duan W, Zhu J, Lou G, Chen G, Cheng Y, Xue F, Nick S, Wang H, Li D. First-line bevacizumab plus chemotherapy in Chinese patients with stage III/IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer: a phase III randomized controlled trial. J Gynecol Oncol. 2024 Sep;35(5):e99. doi: 10.3802/jgo.2024.35.e99. Epub 2024 Apr 22.
PMID: 38872480DERIVEDGaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
PMID: 37185961DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2018
First Posted
August 17, 2018
Study Start
August 15, 2018
Primary Completion
May 26, 2021
Study Completion
May 11, 2023
Last Updated
October 3, 2024
Results First Posted
March 17, 2023
Record last verified: 2024-06