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

NCT04670978 | Unknown Phase 2

• 1 other identifier: AB-PRR-EOC
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Keywords

epithelial ovarian cancer; platinum-resistant recurrent; Abraxane; Bevacizumab Biosimilar

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 6-month progression-free survival rate

  assessed up to 6 months

• progression-free survival

  up to 3 years

• overall survival

  assessed up to 3 years

• Disease control rate

  Assessed at the end of 6 cycle(each cycle is 21 days)

Study Arms (1)

albumin-bound paclitaxe combined with bevacizumab biosimilar

EXPERIMENTAL

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

Drug: albumin-bound paclitaxe combined with bevacizumab biosimilar

Interventions

albumin-bound paclitaxe combined with bevacizumab biosimilar DRUG

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

albumin-bound paclitaxe combined with bevacizumab biosimilar

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Beihua Kong

CONTACT

18560081888; kongbeihua@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of gynaecology and obstetrics

Study Record Dates

• First Submitted: December 5, 2020
• First Posted: December 17, 2020
• Study Start: March 31, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)