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

Hoffmann-La Roche100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (16)

Beijing Obstetrics and Gynecology Hospital, Capital Medical University

Beijing, China

the First Hospital of Jilin University

Changchun, China

Jilin Cancer Hospital

Changchun, China

Xiangya Hospital Central South University

Changsha, China

West China Second University Hospital

Chengdu, China

Fujian Cancer Hospital

Fuzhou, China

Sun Yet-sen University Cancer Center

Guangzhou, China

Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department

Hangzhou, China

Harbin Medical University Cancer Hospital

Harbin, China

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

Nanjing, China

...and 6 more locations

Outcomes

Primary Outcomes

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.

Time frame: Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 24 months)

Secondary Outcomes

Overall Survival (OS)

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 54.1 months)

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.

Time frame: Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 24 months)

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.

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)

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).