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

Lei Li

Status and phase: Unknown; Phase 2

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

Treatments: Combination Product: Albumin-bound paclitaxel and bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT05310344

ALBPAC1

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Patients with platinum-resistant recurrent epithelial ovarian cancer

Experimental group

Treatment:

Combination Product: Albumin-bound paclitaxel and bevacizumab