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

NCT ID: NCT05310344

Last Updated: 2022-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-27

Study Completion Date

2024-03-27

Brief Summary

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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.

Detailed Description

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Conditions

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Ovarian Carcinoma Platinum-resistant Ovarian Cancer Recurrent Ovarian Carcinoma Albumin-bound Paclitaxel Bevacizumab Survival Outcomes Adverse Events

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with platinum-resistant recurrent epithelial ovarian cancer

Group Type EXPERIMENTAL

Albumin-bound paclitaxel and bevacizumab

Intervention Type COMBINATION_PRODUCT

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.

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Lei Li

OTHER

Sponsor Role lead

Responsible Party

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Lei Li

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lei Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Lei Li

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lei Li, M.D.

Role: CONTACT

86-139-1198-8831

Facility Contacts

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Lei Li, M.D.

Role: primary

8613911988831

Other Identifiers

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ALBPAC1

Identifier Type: -

Identifier Source: org_study_id

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