Abraxane With Bevacizumab Biosimilar in Patients With Recurrent, Platinum-resistant Epithelial Ovarian Cancer

Study Overview
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Brief Summary
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The study is a multi-center, prospective, one-arm, phase II clinical trial. It is tend to examine the safety and efficacy of combining abraxane(albumin-bound paclitaxel） and bevacizumab to treat patients with recurrent, platinum-resistant primary epithelial ovarian cancer, fallopian tube cancer or peritoneal carcinoma.

Official Title
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Efficacy and Safety of Abraxane With Bevacizumab Biosimilar in Patients With Recurrent, Platinum-resistant Epithelial Ovarian Cancer：A Multi-center, Prospective, One-arm, Phase II Study

Conditions
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Objective Response Rate

Intervention / Treatment
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* Drug: albumin-bound paclitaxe combined with bevacizumab biosimilar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recurrent or progressive primary EOC, fallopian tube carcinoma or peritoneal carcinoma (PC) within 6 months of their last previous platinum therapy Patients had received at least one prior line of platinum-based chemotherapy Patients were required to have one measurable disease for assessment according to RECIST version 1.1 or determined CA125 level according to GCIG Eastern Cooperative Oncology Group (ECOG) Performance Status rating of 0-1 life expectancy ≥3 months ≥30 days after surgery, the body has recovered and there is no active infection Patients had received at least 1 prior line of platinum-based chemotherapy and were recurrent or progressed within 6 months after the end of the last platinum-based regimen Must have adequate hematologic and hepatic function Subjects of childbearing age must agree to use effective contraception during the trial period and negative for serum or urine pregnancy test Patient provides voluntary written informed consent Exclusion Criteria: Previously received bevacizumab. History of other invasive malignancy with the exception of nonmelanoma skin cancer Participate in other drug trials Blood pressure of >150/100 mmHg on antihypertensive medications Previous history of hypertensive crisis or hypertensive encephalopathy Diagnosed with unstable angina per NYHA or Grade 2 or greater congestive heart failure The history of myocardial infarction within 6 months The history of stroke or transient ischemic attack within 6 months of enrollment Clinically significant vascular disease (e.g., aortic aneurysm, aortic dissection) or symptomatic peripheral vascular disease Bleeding diathesis or coagulopathy Presence of central nervous system or brain metastases Pre-existing peripheral neuropathy of Grade ≥ 2 Major surgery was performed within 28 days prior to enrollment Partial or complete ileus within 3 months prior to study enrollment A biopsy or other minor surgery within 7 days prior to study enrollment Positive pregnancy test or is lactating Abdominal fistula, gastrointestinal perforation or abscess accumulation in the abdominal cavity within 6 months prior to study enrollment Severe, nonhealing wound, ulcer, or bone fracture Serious intercurrent medical or psychiatric illness, including serious active infection Uncontrolled systemic infections require antiinfective treatment Proteinuria at screening as demonstrated by either Urine protein:creatinine (UPC) ratio ≥ 1.0 at screening OR Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible) Known to be allergic, highly sensitive or intolerant to investigational drugs or their excipients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: albumin-bound paclitaxe combined with bevacizumab biosimilar<br>albumin-bound paclitaxel, 260mg/m2，ivdrip，D1，once every three weeks bevacizumab biosimilar, 10mg/kg，ivdrip，D1, once every three weeks | Drug: albumin-bound paclitaxe combined with bevacizumab biosimilar<br>* albumin-bound paclitaxe, 260mg/m2, every 3 weeks, 6cycles, bevacizumab biosimilar, 10mg/kg, every 3 weeks, continue until PD or unaccceptable toxicity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate | Radiologic imaging was scheduled to be performed at baseline, after every third treatment cycle, and at the end of treatment or time of progression unless it was done in the previous four weeks. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; objective response rate (ORR) = CR+PR | Assessed at the end of 6 cycle(each cycle is 21 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-month progression-free survival rate | the percentage of participants with no progression event at 6 months after starting study treatment | assessed up to 6 months | 
| progression-free survival | PFS was measured from day 1 of treatment until time of progression (assessed every 12 weeks) or death, whichever came first | up to 3 years | 
| overall survival | Overall survival is defined as the time from treatment start until death from any cause | assessed up to 3 years | 
| Disease control rate | the percentage of complete and partial response as well as stable disease | Assessed at the end of 6 cycle(each cycle is 21 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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platinum-resistant recurrent, epithelial ovarian cancer, Abraxane, Bevacizumab Biosimilar