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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03635489
• Other study ID #: YO40268
• Status: Completed
• Phase: Phase 3
• Start date: August 15, 2018
• Est. completion date: May 12, 2023

Study information

• Verified date: June 2023
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 12, 2023
• Est. primary completion date: May 26, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Peritoneal Neoplasms
• Primary Peritoneal Cancer

Intervention

Drug:
• Paclitaxel
175 mg/m^2 IV infusion on Day 1 of each 21-day cycle.
• Bevacizumab
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
• Carboplatin
Area Under the Curve (AUC) of 6 mg/ml/min on Day 1 of each 21-day cycle.
• Placebo
Placebo matched to bevacizumab IV infusion on Day 1 of each 21-day cycle.

Locations

Country	Name	City	State
China	Beijing Obstetrics and Gynecology Hospital, Capital Medical University	Beijing City
China	Jilin Cancer Hospital	Changchun
China	the First Hospital of Jilin University	Changchun
China	Xiangya Hospital Central South University	Changsha City
China	West China Second University Hospital	Chengdu City
China	Fujian Cancer Hospital	Fuzhou
China	Sun Yet-sen University Cancer Center	Guangzhou City
China	Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department	Hangzhou City
China	Harbin Medical University Cancer Hospital	Harbin
China	Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School	Nanjing City
China	Guangxi Cancer Hospital of Guangxi Medical University	Nanning
China	Nantong Tumor Hospital	Nantong City
China	Fudan University Shanghai Cancer Center	Shanghai City
China	Tianjin Medical University General Hospital	Tianjin
China	First Affiliated Hospital of Medical College of Xi'an Jiaotong University	Xi'an
China	Henan Cancer Hospital	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Survival (OS)	OS was defined as the time from the date of randomization to the date of death from any cause.	Randomization up to to death from any cause (up to approximately 24 months)
Secondary	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.	Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 24 months)
Secondary	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.	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)
Secondary	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).	From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)
Secondary	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).	From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)
Secondary	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).	From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)
Secondary	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).	From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)
Secondary	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).	From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)
Secondary	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).	From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)
Secondary	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).	From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)
Secondary	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)