Efficacy and Safety of Paclitaxel for Injection (Albumin-bound) in Combination With Carboplatin for First-line Chemotherapy of Ovarian Cancer: A Multicenter, Open-label, Single-arm Phase 2 Clinical Study

Huazhong University of Science and Technology0 sites77 target enrollmentMarch 1, 2019

ConditionsOvarian Cancer

InterventionsPaclitaxel for injection (albumin-bound)

DrugsPaclitaxel for injection (albumin-bound)

Overview

Phase: Phase 2
Intervention: Paclitaxel for injection (albumin-bound)
Conditions: Ovarian Cancer
Sponsor: Huazhong University of Science and Technology
Enrollment: 77
Primary Endpoint: Progression free Survival
Status: Not yet recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

Preliminary evaluation of the efficacy and safety of paclitaxel for injection (albumin-bound) in combination with carboplatin for first-line chemotherapy of ovarian cancer.

Registry

clinicaltrials.gov

Start Date

March 1, 2019

End Date

December 31, 2024

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Huazhong University of Science and Technology

Responsible Party

Principal Investigator

Ding Ma

Director

Huazhong University of Science and Technology

Eligibility Criteria

Inclusion Criteria

•Age: 18 to 75 years;
•Histologically confirmed epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer;
•Patients with stage IC-IV according to the International Federation of Obstetrics and Gynecology (FIGO) and who underwent an ideal tumor reduction procedure within 6 weeks prior to enrollment;
•Lesion is measurable according to RECIST 1.1 criteria or patient's CA125 is evaluable according to GCIG criteria;
•ECOG performance status of 0-2;
•Expected survival ≥ 3 months;
•Bone marrow function: Neutrophils ≥ 1.5×109/L, platelets ≥ 100×109/L, hemoglobin ≥ 90 g/L;
•Hepatic and renal function: Serum creatinine ≤ 1.5×ULN; AST and ALT ≤ 1.5×ULN or ≤ 5×ULN in the presence of hepatic metastasis; Total bilirubin ≤ 1.5×ULN, or ≤ 2.5×ULN in patients with Gilbert's syndrome;
•Must agree to use effective contraception during the trial; Women of childbearing potential must have a negative serum or urine pregnancy test; Non-lactating patients.

Exclusion Criteria

•Ovarian low-grade malignant tumor patients;
•Patients who have received abdominal or pelvic radiotherapy;
•Patients with central nervous system disease or brain metastases;
•Other malignancies have occurred within the last 5 years, except for cervical carcinoma in situ, non-melanoma skin cancers that have been cured;
•Prior Grade ≥ 2 sensory or motor neuropathy;
•Uncontrolled serious medical conditions that, in the opinion of the investigator, would affect the ability of the subject to receive the study regimen, such as concomitant serious medical conditions, including severe heart disease, cerebrovascular disease, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.;
•Known to be hypersensitive, highly sensitive, or intolerant to study-related medications or their excipients;
•Receive other study drug chemotherapy within 30 days of the first dose of chemotherapy;
•Patients not suitable for participation in this study judged by investigator.