Clinical trial NCT05310344: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ovarian Carcinoma
Platinum-resistant Ovarian Cancer
Recurrent Ovarian Carcinoma
Albumin-bound Paclitaxel
Bevacizumab
Survival Outcomes
Adverse Events
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: 24 months
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 24 months
measure: Overall survival
timeFrame: 36 months
measure: Adverse Events
timeFrame: 36 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References: