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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    96
  • sponsor
    Shandong University
Updated on 14 October 2021

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.

Details
Condition Objective Response Rate
Treatment albumin-bound paclitaxe combined with bevacizumab biosimilar
Clinical Study IdentifierNCT04670978
SponsorShandong University
Last Modified on14 October 2021

Eligibility

Yes No Not Sure

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
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