Epithelial Ovarian Carcinoma Stage III, Epithelial Ovarian Carcinoma Stage IV, Fallopian Tube Carcinoma Stage III, Fallopian Tube Carcinoma Stage IV, Primary Peritoneal Carcinoma Stage III, Primary Peritoneal Carcinoma Stage IV
Conditions
Brief 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.
Detailed description
One of the major challenges related to solvent-based taxanes administration in clinical practice is the high rate of hypersensitivity reactions (HSRs). Nab-paclitaxel has showed its considerable survival and low toxicity profiles in first-line treatment for several solid tumors and is recommended as a treatment for recurrent epithelial ovarian cancer (EOC). We focus on clinical efficacy and safety outcomes of nab-paclitaxel in current clinical studies of primary EOC treatment and aim to explore the potential feasibility of nab-paclitaxel as the first-line treatment for EOC, primary peritoneal carcinoma or fallopian tube carcinoma.
Interventions
DRUGnab-paclitaxel combined with carboplatin
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)
Sponsors
Jiaxing Maternity and Child Health Care Hospital
Zhejiang University
Second Affiliated Hospital, School of Medicine, Zhejiang University
First Affiliated Hospital of Wenzhou Medical University
Second Affiliated Hospital of Wenzhou Medical University
Sun Yat-sen University
Qilu Hospital of Shandong University
Ningbo No. 1 Hospital
Ningbo Women & Children's Hospital
Sir Run Run Shaw Hospital
Women's Hospital School Of Medicine Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 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 2. Physical condition Eastern Cooperative Oncology Group PS score: 0-2 points 3. Participants who had not participated in other drug clinical trials within 4 weeks prior to enrollment 4. Written informed consent 5. Expected survival ≥6 months 6. The disease met the criteria for Efficacy Evaluation of solid tumors (RECIST 1.1) 7. Be able to comply with outpatient treatment, laboratory monitoring, and necessary clinical visits during study participation.
Exclusion criteria
1. Patients with low malignant potential ovarian tumors; 2. Other malignant tumors within the previous 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer; 3. Patients who have previously received chemotherapy or radiotherapy for pelvic cavity; 4. Patients with central nervous system metastasis or peripheral neuropathy \> grade 1; 5. Patients with severe myelosuppression, severe liver dysfunction (Child's Class III), or renal dysfunction at the time of screening; 6. 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; 7. Uncontrolled systemic infection requiring anti-infective treatment; 8. 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; 9. Patients who are allergic to the active ingredients or excipients of albumin paclitaxel and carboplatin for injection; 10. Pregnant or lactating women; 11. Those who were considered unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | 20 months | Disease progression as first failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Remission Rate | 12 months | The target lesion disappeared for at least 4 weeks,Tumor volume reduced by at least 30 percent. |
| Survival | 3 years, 5 years | Overall survival (all-cause death) |
| Adverse events | 3 years, 5 years | Treatment-related symptoms |
Countries
China
Contacts
Primary ContactYaxia Chen, MD
Backup ContactYang Li, MD
Outcome results
None listed