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

NCT ID: NCT04670978

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-31
• Study Completion Date: 2024-12-31

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.

Conditions

Objective Response Rate

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

albumin-bound paclitaxe combined with bevacizumab biosimilar

albumin-bound paclitaxel, 260mg/m2，ivdrip，D1，once every three weeks bevacizumab biosimilar, 10mg/kg，ivdrip，D1, once every three weeks

Group Type: EXPERIMENTAL

albumin-bound paclitaxe combined with bevacizumab biosimilar

Intervention Type: DRUG

albumin-bound paclitaxe, 260mg/m2, every 3 weeks, 6cycles, bevacizumab biosimilar, 10mg/kg, every 3 weeks, continue until PD or unaccceptable toxicity

Interventions

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Beihua Kong

Head of gynaecology and obstetrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Beihua Kong

Role: CONTACT

kongbeihua@sdu.edu.cn

18560081888

Facility Contacts

Beihua Kong, MD. PhD.

Role: primary

kongbeihua@sdu.edu.cn

+8618560081888

Other Identifiers

AB-PRR-EOC

Identifier Type: -

Identifier Source: org_study_id