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

Objective Response Rate Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04670978
• Other study ID #: AB-PRR-EOC
• Status: Recruiting
• Phase: Phase 2
• Start date: March 31, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: Shandong University
• Contact: Beihua Kong
• Phone: 18560081888
• Email: kongbeihua[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Objective Response Rate
• Ovarian Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

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