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Albumin-bound Paclitaxel and Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer

Primary Purpose

Ovarian Carcinoma, Platinum-resistant Ovarian Cancer, Recurrent Ovarian Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Albumin-bound paclitaxel and bevacizumab
Sponsored by
Lei Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria

  1. Aged 18~75 years old
  2. Histologically confirmed platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer
  3. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
  5. Sufficient bone marrow function;
  6. Sufficient liver and renal function;
  7. Patients of reproductive potential were required to take effective contraceptive measures for the duration of the study and had a negative serum or urine pregnancy test result; non-lactating women;
  8. Patients had no disturbance of consciousness and volunteered to participate in the study.

Exclusion Criteria

  1. Uncontrolled hypertension
  2. Tumor invading vital blood vessels
  3. With contraindications to chemotherapy
  4. With uncontrolled infection
  5. Patients had received anticancer therapy within 3 weeks before enrollment
  6. Patients were allergic or intolerant to investigational drugs or its ingredients
  7. Patients are not suitable for this trial as judged by investigators

Sites / Locations

  • Lei LiRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with platinum-resistant recurrent epithelial ovarian cancer

Arm Description

Outcomes

Primary Outcome Measures

Objective response rate (ORR)
ORR is defined as the percentage of participants in the analysis population who have a complete or partial remission per RECIST 1.1

Secondary Outcome Measures

Progression-Free Survival (PFS)
PFS defined as the time the duration from date of enrollment to the first documented disease progression per RECIST v1.1, or death due to any cause, whichever occurs first
Overall survival
Overall survival is defined as the duration from date of enrollment to the date of death from any cause
Adverse Events
Adverse event (AE), Treatment emergent adverse event (TEAE), Serious adverse event (SAE)

Full Information

First Posted
March 26, 2022
Last Updated
March 26, 2022
Sponsor
Lei Li
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1. Study Identification

Unique Protocol Identification Number
NCT05310344
Brief Title
Albumin-bound Paclitaxel and Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer
Official Title
Albumin-bound Paclitaxel and Bevacizumab for Platinum-resistant Recurrent Epithelial Ovarian Cancer: A Single-arm, Multi-center, Phase II Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2022 (Actual)
Primary Completion Date
March 27, 2023 (Anticipated)
Study Completion Date
March 27, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lei Li

4. Oversight

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

5. Study Description

Brief Summary
This study is a prospective, multicenter, phase II clinical trial to evaluate the efficacy and safety of albumin-bound paclitaxel combined with bevacizumab for platinum-resistant recurrent epithelial ovarian cancer. Patients with platinum-resistant recurrent ovarian cancer who meet the inclusion criteria, and don't meet any of the exclusion criteria, are enrolled in the study. They will receive albumin-bound paclitaxel (260 mg/m2) and bevacizumab (7.5mg/kg) intravenously every 21 days. Treatment continue until disease progression, intolerable toxicity, or patient refusal. Objective response rates primary objective. Progression-free survival, overall survival, and safety are secondary objectives. The study will enroll a total of 50 patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Carcinoma, Platinum-resistant Ovarian Cancer, Recurrent Ovarian Carcinoma, Albumin-bound Paclitaxel, Bevacizumab, Survival Outcomes, Adverse Events

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Patients with platinum-resistant recurrent epithelial ovarian cancer
Arm Type
Experimental
Intervention Type
Combination Product
Intervention Name(s)
Albumin-bound paclitaxel and bevacizumab
Intervention Description
Patients will receive albumin-bound paclitaxel (260 mg/m2) and bevacizumab (7.5mg/kg) intravenously every 21 days. The total treatment periods are no more than 6 cycles.
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
ORR is defined as the percentage of participants in the analysis population who have a complete or partial remission per RECIST 1.1
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
PFS defined as the time the duration from date of enrollment to the first documented disease progression per RECIST v1.1, or death due to any cause, whichever occurs first
Time Frame
24 months
Title
Overall survival
Description
Overall survival is defined as the duration from date of enrollment to the date of death from any cause
Time Frame
36 months
Title
Adverse Events
Description
Adverse event (AE), Treatment emergent adverse event (TEAE), Serious adverse event (SAE)
Time Frame
36 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Aged 18~75 years old Histologically confirmed platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; Sufficient bone marrow function; Sufficient liver and renal function; Patients of reproductive potential were required to take effective contraceptive measures for the duration of the study and had a negative serum or urine pregnancy test result; non-lactating women; Patients had no disturbance of consciousness and volunteered to participate in the study. Exclusion Criteria Uncontrolled hypertension Tumor invading vital blood vessels With contraindications to chemotherapy With uncontrolled infection Patients had received anticancer therapy within 3 weeks before enrollment Patients were allergic or intolerant to investigational drugs or its ingredients Patients are not suitable for this trial as judged by investigators
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Li, M.D.
Phone
86-139-1198-8831
Email
lileigh@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lei Li, M.D.
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lei Li
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Li, M.D.
Phone
8613911988831
Email
lileigh@163.com

12. IPD Sharing Statement

Learn more about this trial

Albumin-bound Paclitaxel and Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer

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