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
- Conditions
- Ovarian CancerFallopian Tube CancerPrimary Peritoneal Cancer
- Interventions
- Registration Number
- NCT03635489
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bevacizumab + Paclitaxel + Carboplatin Bevacizumab Participants 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 Participants 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. Bevacizumab + Paclitaxel + Carboplatin Paclitaxel Participants 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. Bevacizumab + Paclitaxel + Carboplatin Carboplatin Participants 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 Paclitaxel Participants 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. Placebo + Paclitaxel + Carboplatin Carboplatin Participants 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.
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 24 months) 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.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) Randomization up to to death from any cause (up to approximately 54.1 months) OS was defined as the time from the date of randomization to the date of death from any cause.
Objective Response Rate (ORR) Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 24 months) ORR was defined as the proportion of participants with complete response (CR) or partial response (PR) as assessed by investigator according to RECIST v.1.1.
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) A clinically meaningful improvement in patient-reported abdominal pain or bloating was defined as a ≥10-point decrease from the linearly transformed 0-100 point baseline symptom scale score on each of two items from the Abdominal/Gastrointestinal Symptom Scale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28).
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) DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression,as assessed by the Investigator using RECIST v1.1, or death from any cause, whichever occurred first. DOR was evaluated for participants who had a objective response of CR or PR.
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) A clinically meaningful improvement in patient-reported abdominal pain or bloating was defined as a ≥10-point decrease from the linearly transformed 0-100 point baseline symptom scale score on each of two items from the Abdominal/Gastrointestinal Symptom Scale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28).
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Physical) From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months) A clinically meaningful improvement in patient-reported function and HRQoL was defined as a \>10-point increase from the linearly transformed 0-100 point baseline scale score on each of the four functional (physical, role, emotional, social) scales and global health status/HRQoL scale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30).
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Role) From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months) A clinically meaningful improvement in patient-reported function and HRQoL was defined as a \>10-point increase from the linearly transformed 0-100 point baseline scale score on each of the four functional (physical, role, emotional, social) scales and global health status/HRQoL scale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30).
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Social) From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months) A clinically meaningful improvement in patient-reported function and HRQoL was defined as a \>10-point increase from the linearly transformed 0-100 point baseline scale score on each of the four functional (physical, role, emotional, social) scales and global health status/HRQoL scale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30).
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Emotional) From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months) A clinically meaningful improvement in patient-reported function and HRQoL was defined as a \>10-point increase from the linearly transformed 0-100 point baseline scale score on each of the four functional (physical, role, emotional, social) scales and global health status/HRQoL scale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30).
Pecentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Health Related Quality of Life (HRQoL) From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months) A clinically meaningful improvement in patient-reported function and HRQoL was defined as a \>10-point increase from the linearly transformed 0-100 point baseline scale score on each of the four functional (physical, role, emotional, social) scales and global health status/HRQoL scale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30).
Percentage of Participants With Adverse Events (AEs) From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)
Trial Locations
- Locations (16)
the First Hospital of Jilin University
🇨🇳Changchun, China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
🇨🇳Nanjing City, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, China
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
🇨🇳Beijing City, China
Fujian Cancer Hospital
🇨🇳Fuzhou, China
Xiangya Hospital Central South University
🇨🇳Changsha City, China
West China Second University Hospital
🇨🇳Chengdu City, China
Jilin Cancer Hospital
🇨🇳Changchun, China
Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department
🇨🇳Hangzhou City, China
Guangxi Cancer Hospital of Guangxi Medical University
🇨🇳Nanning, China
Nantong Tumor Hospital
🇨🇳Nantong City, China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
🇨🇳Xi'an, China
Henan Cancer Hospital
🇨🇳Zhengzhou, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, China
Sun Yet-sen University Cancer Center
🇨🇳Guangzhou City, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai City, China