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

Sponsor

Shandong University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04670978

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Objective Response Rate	Drug: albumin-bound paclitaxe combined with bevacizumab biosimilar	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

96 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 31, 2021

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: albumin-bound paclitaxe combined with bevacizumab biosimilar 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 albumin-bound paclitaxe, 260mg/m2, every 3 weeks, 6cycles, bevacizumab biosimilar, 10mg/kg, every 3 weeks, continue until PD or unaccceptable toxicity

Arm

Intervention/Treatment

Experimental: albumin-bound paclitaxe combined with bevacizumab biosimilar

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

albumin-bound paclitaxe, 260mg/m2, every 3 weeks, 6cycles, bevacizumab biosimilar, 10mg/kg, every 3 weeks, continue until PD or unaccceptable toxicity

Outcome Measures

Primary Outcome Measures

objective response rate [Assessed at the end of 6 cycle(each cycle is 21 days)]
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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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