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

Primary Purpose

Objective Response Rate

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
albumin-bound paclitaxe combined with bevacizumab biosimilar
Sponsored by
Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Objective Response Rate focused on measuring epithelial ovarian cancer, platinum-resistant recurrent, Abraxane, Bevacizumab Biosimilar

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Qilu Hospital of Shandong UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

albumin-bound paclitaxe combined with bevacizumab biosimilar

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

6-month progression-free survival rate
the percentage of participants with no progression event at 6 months after starting study treatment
progression-free survival
PFS was measured from day 1 of treatment until time of progression (assessed every 12 weeks) or death, whichever came first
overall survival
Overall survival is defined as the time from treatment start until death from any cause
Disease control rate
the percentage of complete and partial response as well as stable disease

Full Information

First Posted
December 5, 2020
Last Updated
April 23, 2023
Sponsor
Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT04670978
Brief Title
Abraxane With Bevacizumab Biosimilar in Patients With Recurrent, Platinum-resistant Epithelial Ovarian Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Objective Response Rate
Keywords
epithelial ovarian cancer, platinum-resistant recurrent, Abraxane, Bevacizumab Biosimilar

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
albumin-bound paclitaxe combined with bevacizumab biosimilar
Arm Type
Experimental
Arm Description
albumin-bound paclitaxel, 260mg/m2,ivdrip,D1,once every three weeks bevacizumab biosimilar, 10mg/kg,ivdrip,D1, once every three weeks
Intervention Type
Drug
Intervention Name(s)
albumin-bound paclitaxe combined with bevacizumab biosimilar
Intervention Description
albumin-bound paclitaxe, 260mg/m2, every 3 weeks, 6cycles, bevacizumab biosimilar, 10mg/kg, every 3 weeks, continue until PD or unaccceptable toxicity
Primary Outcome Measure Information:
Title
objective response rate
Description
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
Time Frame
Assessed at the end of 6 cycle(each cycle is 21 days)
Secondary Outcome Measure Information:
Title
6-month progression-free survival rate
Description
the percentage of participants with no progression event at 6 months after starting study treatment
Time Frame
assessed up to 6 months
Title
progression-free survival
Description
PFS was measured from day 1 of treatment until time of progression (assessed every 12 weeks) or death, whichever came first
Time Frame
up to 3 years
Title
overall survival
Description
Overall survival is defined as the time from treatment start until death from any cause
Time Frame
assessed up to 3 years
Title
Disease control rate
Description
the percentage of complete and partial response as well as stable disease
Time Frame
Assessed at the end of 6 cycle(each cycle is 21 days)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beihua Kong
Phone
18560081888
Email
kongbeihua@sdu.edu.cn
Facility Information:
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beihua Kong, MD. PhD.
Phone
+8618560081888
Email
kongbeihua@sdu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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

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