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

Last updated: April 23, 2023
Sponsor: Shandong University
Overall Status: Active - Recruiting

Phase

2

Condition

Ovarian Cysts

Treatment

N/A

Clinical Study ID

NCT04670978
AB-PRR-EOC
  • Ages 18-70
  • Female

Study 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

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 toRECIST 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 wererecurrent or progressed within 6 months after the end of the last platinum-basedregimen
  8. Must have adequate hematologic and hepatic function
  9. Subjects of childbearing age must agree to use effective contraception during thetrial period and negative for serum or urine pregnancy test
  10. Patient provides voluntary written informed consent

Exclusion

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) orsymptomatic 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 theabdominal 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 activeinfection
  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 ondipstick urinalysis at baseline should undergo a 24 hour urine collection and mustdemonstrate ≤ 1g of protein in 24 hours to be eligible)
  24. Known to be allergic, highly sensitive or intolerant to investigational drugs or theirexcipients

Study Design

Total Participants: 96
Study Start date:
March 31, 2021
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Qilu Hospital of Shandong University

    Jinan, Shandong 250012
    China

    Active - Recruiting

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