Clinical trial NCT04670978: Abraxane With Bevacizumab Biosimilar in Patients With Recurrent, Platinum-resistant Epithelial Ovarian Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Objective Response Rate
Keywords: epithelial ovarian cancer
platinum-resistant recurrent
Abraxane
Bevacizumab Biosimilar
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Recurrent or progressive primary EOC, fallopian tube carcinoma or peritoneal carcinoma (PC) within 6 months of their last previous platinum therapy
2. Patients had received at least one prior line of platinum-based chemotherapy
3. Patients were required to have one measurable disease for assessment according to RECIST version 1.1 or determined CA125 level according to GCIG
4. Eastern Cooperative Oncology Group (ECOG) Performance Status rating of 0-1
5. life expectancy ≥3 months
6. ≥30 days after surgery, the body has recovered and there is no active infection
7. 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
8. Must have adequate hematologic and hepatic function
9. Subjects of childbearing age must agree to use effective contraception during the trial period and negative for serum or urine pregnancy test
10. Patient provides voluntary written informed consent

Exclusion Criteria:

1. Previously received bevacizumab.
2. History of other invasive malignancy with the exception of nonmelanoma skin cancer
3. Participate in other drug trials
4. Blood pressure of \>150/100 mmHg on antihypertensive medications
5. Previous history of hypertensive crisis or hypertensive encephalopathy
6. Diagnosed with unstable angina per NYHA or Grade 2 or greater congestive heart failure
7. The history of myocardial infarction within 6 months
8. The history of stroke or transient ischemic attack within 6 months of enrollment
9. Clinically significant vascular disease (e.g., aortic aneurysm, aortic dissection) or symptomatic peripheral vascular disease
10. Bleeding diathesis or coagulopathy
11. Presence of central nervous system or brain metastases
12. Pre-existing peripheral neuropathy of Grade ≥ 2
13. Major surgery was performed within 28 days prior to enrollment
14. Partial or complete ileus within 3 months prior to study enrollment
15. A biopsy or other minor surgery within 7 days prior to study enrollment
16. Positive pregnancy test or is lactating
17. Abdominal fistula, gastrointestinal perforation or abscess accumulation in the abdominal cavity within 6 months prior to study enrollment
18. Severe, nonhealing wound, ulcer, or bone fracture
19. Serious intercurrent medical or psychiatric illness, including serious active infection
20. Uncontrolled systemic infections require antiinfective treatment
21. Proteinuria at screening as demonstrated by either
22. Urine protein:creatinine (UPC) ratio ≥ 1.0 at screening OR
23. 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)
24. Known to be allergic, highly sensitive or intolerant to investigational drugs or their excipients

Primary outcomes:
measure: objective response rate
timeFrame: Assessed at the end of 6 cycle(each cycle is 21 days)
Secondary outcomes:
measure: 6-month progression-free survival rate
timeFrame: assessed up to 6 months
measure: progression-free survival
timeFrame: up to 3 years
measure: overall survival
timeFrame: assessed up to 3 years
measure: Disease control rate
timeFrame: Assessed at the end of 6 cycle(each cycle is 21 days)
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
References: