Clinical trial NCT03635489: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2018-08-17
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 24 months)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Randomization up to to death from any cause (up to approximately 54.1 months)
measure: Objective Response Rate (ORR)
timeFrame: Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 24 months)
measure: Duration of Response (DOR)
timeFrame: 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)
measure: Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Abdominal Pain
timeFrame: From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)
measure: Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Bloating
timeFrame: From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)
measure: Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Physical)
timeFrame: From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)
measure: Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Role)
timeFrame: From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)
measure: Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Social)
timeFrame: From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)
measure: Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Emotional)
timeFrame: From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)
measure: Pecentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Health Related Quality of Life (HRQoL)
timeFrame: From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: 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)
Other outcomes:
Locations:
city: Beijing City
country: China
facility: Beijing Obstetrics and Gynecology Hospital, Capital Medical University
city: Changchun
country: China
facility: the First Hospital of Jilin University
city: Changchun
country: China
facility: Jilin Cancer Hospital
city: Changsha City
country: China
facility: Xiangya Hospital Central South University
city: Chengdu City
country: China
facility: West China Second University Hospital
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Guangzhou City
country: China
facility: Sun Yet-sen University Cancer Center
city: Hangzhou City
country: China
facility: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Nanjing City
country: China
facility: Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
city: Nanning City
country: China
facility: Guangxi Cancer Hospital of Guangxi Medical University
city: Nantong City
country: China
facility: Nantong Tumor Hospital
city: Shanghai City
country: China
facility: Fudan University Shanghai Cancer Center
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Xi'an
country: China
facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: