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

Recurrent Ovarian Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05310344
• Other study ID #: ALBPAC1
• Status: Recruiting
• Phase: Phase 2
• Start date: March 27, 2022
• Est. completion date: March 27, 2024

Study information

• Verified date: March 2022
• Source: Peking Union Medical College Hospital
• Contact: Lei Li, M.D.
• Phone: 86-139-1198-8831
• Email: lileigh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 27, 2024
• Est. primary completion date: March 27, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adverse Events
• Bevacizumab
• Carcinoma
• Carcinoma, Ovarian Epithelial
• Ovarian Carcinoma
• Ovarian Neoplasms
• Platinum-resistant Ovarian Cancer
• Recurrent Ovarian Carcinoma
• Survival Outcomes

Intervention

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.

Locations

Country	Name	City	State
China	Lei Li	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 months
Secondary	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	24 months
Secondary	Overall survival	Overall survival is defined as the duration from date of enrollment to the date of death from any cause	36 months
Secondary	Adverse Events	Adverse event (AE), Treatment emergent adverse event (TEAE), Serious adverse event (SAE)	36 months