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

NCT ID: NCT03818282

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2024-12-31

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paclitaxel for injection (albumin-bound)

Group Type: EXPERIMENTAL

Paclitaxel for injection (albumin-bound)

Intervention Type: DRUG

Paclitaxel for injection (albumin-bound) 260 mg/m2, i.v., d1; AUC = 5 for carboplatin injection, i.v., infusion completed on day 1-3; Repeated every 3-4 weeks for 6-8 cycles.

Interventions

Paclitaxel for injection (albumin-bound)

Paclitaxel for injection (albumin-bound) 260 mg/m2, i.v., d1; AUC = 5 for carboplatin injection, i.v., infusion completed on day 1-3; Repeated every 3-4 weeks for 6-8 cycles.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Ding Ma

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ding Ma, M.D.

Role: CONTACT

dma@tjh.tjmu.edu.cn

02783663351

Danhui Weng, M.D.

Role: CONTACT

weng.dh@gmail.com

02783663351

Other Identifiers

2019-GYN/OC-01

Identifier Type: -

Identifier Source: org_study_id