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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 16
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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.
研究组 & 干预措施
Bevacizumab + Paclitaxel + 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.
干预措施: Paclitaxel (Drug)
Bevacizumab + Paclitaxel + 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.
干预措施: Bevacizumab (Drug)
Bevacizumab + Paclitaxel + 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.
干预措施: Carboplatin (Drug)
Placebo + Paclitaxel + 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.
干预措施: Paclitaxel (Drug)
Placebo + Paclitaxel + 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.
干预措施: Carboplatin (Drug)
Placebo + Paclitaxel + 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.
干预措施: Placebo (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: 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.
次要结局
- Overall Survival (OS)(Randomization up to to death from any cause (up to approximately 54.1 months))
- Objective Response Rate (ORR)(Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 24 months))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))