Status:
UNKNOWN
Abraxane With Bevacizumab Biosimilar in Patients With Recurrent, Platinum-resistant Epithelial Ovarian Cancer
Lead Sponsor:
Shandong University
Conditions:
Objective Response Rate
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
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 patie...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT04670978
Start Date
March 31 2021
End Date
December 31 2024
Last Update
April 25 2023
Active Locations (1)
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1
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012