Back to resultsA 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
Primary Purpose
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Paclitaxel
Bevacizumab
Carboplatin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer
Eligibility Criteria
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 anticoagulant regimen.
- Enrollment between 1 and 12 weeks after initial surgery is performed for the combined purpose of diagnosis, staging, and cytoreduction
Exclusion Criteria:
- 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.
Sites / Locations
- Beijing Obstetrics and Gynecology Hospital, Capital Medical University
- the First Hospital of Jilin University
- Jilin Cancer Hospital
- Xiangya Hospital Central South University
- West China Second University Hospital
- Fujian Cancer Hospital
- Sun Yet-sen University Cancer Center
- Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department
- Harbin Medical University Cancer Hospital
- Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
- Guangxi Cancer Hospital of Guangxi Medical University
- Nantong Tumor Hospital
- Fudan University Shanghai Cancer Center
- Tianjin Medical University General Hospital
- First Affiliated Hospital of Medical College of Xi'an Jiaotong University
- Henan Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Bevacizumab + Paclitaxel + Carboplatin
Placebo + Paclitaxel + Carboplatin
Arm Description
Participants will receive paclitaxel, carboplatin intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting from Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab for a total of 21 cycles of bevacizumab in the absence of disease progression, unacceptable toxicity, or withdrawal, whichever occurs first.
Participants will receive paclitaxel, carboplatin IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and placebo IV infusion starting from Cycle 2 for a total of 5 cycles, followed by maintenance therapy placebo for a total of 21 cycles of placebo in the absence of disease progression, unacceptable toxicity, or withdrawal, whichever occurs first.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Overall Survival (OS)
OS was defined as the time from the date of randomization to the date of death from any cause.
Objective Response Rate (ORR)
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.
Duration of Response (DOR)
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 Abdominal Pain
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 Bloating
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)
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)
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)
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)
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)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03635489
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
May 26, 2021 (Actual)
Study Completion Date
May 12, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bevacizumab + Paclitaxel + Carboplatin
Arm Type
Experimental
Arm Description
Participants will receive paclitaxel, carboplatin intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting from Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab for a total of 21 cycles of bevacizumab in the absence of disease progression, unacceptable toxicity, or withdrawal, whichever occurs first.
Arm Title
Placebo + Paclitaxel + Carboplatin
Arm Type
Placebo Comparator
Arm Description
Participants will receive paclitaxel, carboplatin IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and placebo IV infusion starting from Cycle 2 for a total of 5 cycles, followed by maintenance therapy placebo for a total of 21 cycles of placebo in the absence of disease progression, unacceptable toxicity, or withdrawal, whichever occurs first.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
175 mg/m^2 IV infusion on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Area Under the Curve (AUC) of 6 mg/ml/min on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matched to bevacizumab IV infusion on Day 1 of each 21-day cycle.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
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.
Time Frame
Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 24 months)
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS was defined as the time from the date of randomization to the date of death from any cause.
Time Frame
Randomization up to to death from any cause (up to approximately 24 months)
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 24 months)
Title
Duration of Response (DOR)
Description
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.
Time Frame
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)
Title
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Abdominal Pain
Description
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).
Time Frame
From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)
Title
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Bloating
Description
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).
Time Frame
From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)
Title
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Physical)
Description
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).
Time Frame
From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)
Title
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Role)
Description
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).
Time Frame
From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)
Title
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Social)
Description
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).
Time Frame
From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)
Title
Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Emotional)
Description
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).
Time Frame
From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)
Title
Pecentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Health Related Quality of Life (HRQoL)
Description
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).
Time Frame
From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)
Title
Percentage of Participants With Adverse Events (AEs)
Time Frame
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)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 anticoagulant regimen.
Enrollment between 1 and 12 weeks after initial surgery is performed for the combined purpose of diagnosis, staging, and cytoreduction
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
City
Beijing City
ZIP/Postal Code
100006
Country
China
Facility Name
the First Hospital of Jilin University
City
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
ZIP/Postal Code
132013
Country
China
Facility Name
Xiangya Hospital Central South University
City
Changsha City
ZIP/Postal Code
410008
Country
China
Facility Name
West China Second University Hospital
City
Chengdu City
ZIP/Postal Code
610066
Country
China
Facility Name
Fujian Cancer Hospital
City
Fuzhou
ZIP/Postal Code
350014
Country
China
Facility Name
Sun Yet-sen University Cancer Center
City
Guangzhou City
ZIP/Postal Code
510663
Country
China
Facility Name
Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department
City
Hangzhou City
ZIP/Postal Code
310022
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
ZIP/Postal Code
150081
Country
China
Facility Name
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
City
Nanjing City
ZIP/Postal Code
210008
Country
China
Facility Name
Guangxi Cancer Hospital of Guangxi Medical University
City
Nanning
ZIP/Postal Code
530021
Country
China
Facility Name
Nantong Tumor Hospital
City
Nantong City
ZIP/Postal Code
226361
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai City
ZIP/Postal Code
200120
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
City
Xi'an
ZIP/Postal Code
710061
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
12. IPD Sharing Statement
Learn more about this trial
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
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