Efficacy and Safety of Paclitaxel for Injection (Albumin-bound) for First-line Chemotherapy of Ovarian Cancer (OC-01)

Huazhong University of Science and Technology

Status and phase

Not yet enrolling

Phase 2

Conditions

Ovarian Cancer

Treatments

Drug: Paclitaxel for injection (albumin-bound)

Study type

Interventional

Funder types

Other

Identifiers

NCT03818282

2019-GYN/OC-01

Details and patient eligibility

About

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

Enrollment

77 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.