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

Sponsor

Lei Li (Other)

Overall Status

Recruiting

CT.gov ID

NCT05310344

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Carcinoma Platinum-resistant Ovarian Cancer Recurrent Ovarian Carcinoma Albumin-bound Paclitaxel Bevacizumab Survival Outcomes Adverse Events	Combination Product: Albumin-bound paclitaxel and bevacizumab	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Albumin-bound Paclitaxel and Bevacizumab for Platinum-resistant Recurrent Epithelial Ovarian Cancer: A Single-arm, Multi-center, Phase II Clinical Study

Actual Study Start Date :

Mar 27, 2022

Anticipated Primary Completion Date :

Mar 27, 2023

Anticipated Study Completion Date :

Mar 27, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients with platinum-resistant recurrent epithelial ovarian cancer	Combination Product: Albumin-bound paclitaxel and bevacizumab 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.

Arm

Intervention/Treatment

Experimental: Patients with platinum-resistant recurrent epithelial ovarian cancer

Combination Product: Albumin-bound paclitaxel and bevacizumab

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.

Outcome Measures

Primary Outcome Measures

Objective response rate (ORR) [24 months]
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) [24 months]
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 [36 months]
Overall survival is defined as the duration from date of enrollment to the date of death from any cause
Adverse Events [36 months]
Adverse event (AE), Treatment emergent adverse event (TEAE), Serious adverse event (SAE)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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