Nab-paclitaxel Versus Sb-taxanes As First-Line Treatment in Advanced Ovarian Cancer
Nab-paclitaxel Versus Solvent-based Taxanes As First-Line Treatment for Patients With Advanced Ovarian Cancer
Women's Hospital School Of Medicine Zhejiang University
538 participants
Nov 27, 2023
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to compare the efficacy and safety of nab-paclitaxel with solvent-based taxanes as first-line treatment for patients with advanced primary epithelial ovarian cancer (EOC), primary peritoneal carcinoma or fallopian tube carcinoma.
Eligibility
Inclusion Criteria7
- Epithelial ovarian cancer/tubal cancer/peritoneal cancer was diagnosed by histopathology or hydroexfoliation cytopathology of the chest and abdomen, and was classified as stage III-IV according to FIGO（International Federation of Gynecology and Obstetrics）stage
- Physical condition Eastern Cooperative Oncology Group PS score: 0-2 points
- Participants who had not participated in other drug clinical trials within 4 weeks prior to enrollment
- Written informed consent
- Expected survival ≥6 months
- The disease met the criteria for Efficacy Evaluation of solid tumors (RECIST 1.1)
- Be able to comply with outpatient treatment, laboratory monitoring, and necessary clinical visits during study participation.
Exclusion Criteria11
- Patients with low malignant potential ovarian tumors;
- Other malignant tumors within the previous 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer;
- Patients who have previously received chemotherapy or radiotherapy for pelvic cavity;
- Patients with central nervous system metastasis or peripheral neuropathy \> grade 1;
- Patients with severe myelosuppression, severe liver dysfunction (Child's Class III), or renal dysfunction at the time of screening;
- Severe cardiovascular disease: Grade Ⅱ or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥470 ms); According to NYHA（New York Heart Association） criteria, patients with grade Ⅲ to Ⅳ cardiac insufficiency or left ventricular ejection fraction (LVEF) \< 55% indicated by color Doppler ultrasonography;
- Uncontrolled systemic infection requiring anti-infective treatment;
- Arteriovenous thrombosis events occurring within 6 months before randomization, such as cardiovascular and cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction, myocardial infarction), deep vein thrombosis and pulmonary embolism;
- Patients who are allergic to the active ingredients or excipients of albumin paclitaxel and carboplatin for injection;
- Pregnant or lactating women;
- Those who were considered unsuitable for inclusion by the researchers.
Interventions
Nab-Paclitaxel/carboplatin q3weeks Nab-Paclitaxel 260 mg/m² IV followed by carboplatin AUC（area under the curve） 5 IV Day1 Repeat every 21 days x 6 cycles Nab-Paclitaxel/carboplatin weekly Dose-dense Nab-Paclitaxel 100 mg/m2 IV followed by carboplatin AUC（area under the curve）2 IV Davs 1. 8, and 15 ·Repeat every 21 days x 6 cycles Paclitaxel 175 mg/m² IV followed by carboplatin AUC（area under the curve）5 IV Day·1Repeat every 21 days x 6 cycles Paclitaxel weekly/carboplatin weekly Paclitaxel 60 mg/m2 followed by carboplatin AUC（area under the curve）2 IV Days 1.8. and 15: repeat every 21 days 6 cycles (18 weeks)
Locations(11)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05737303