Nab-paclitaxel Versus Sb-taxanes As First-Line Treatment in Advanced Ovarian Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Nab-paclitaxel Versus Solvent-based Taxanes As First-Line Treatment for Patients With Advanced Ovarian Cancer

Conditions
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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

Intervention / Treatment
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* Drug: nab-paclitaxel combined with carboplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nab-Paclitaxel/carboplatin for systemic therapy after surgery<br>Nab-Paclitaxel/carboplatin q3 weeks 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 | Drug: nab-paclitaxel combined with carboplatin<br>* 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)<br>* Other names: paclitaxel combined with carboplatin;|
| Active Comparator: Paclitaxel/carboplatin for systemic therapy<br>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) | Drug: nab-paclitaxel combined with carboplatin<br>* 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)<br>* Other names: paclitaxel combined with carboplatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | Disease progression as first failure | 20 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Remission Rate | The target lesion disappeared for at least 4 weeks,Tumor volume reduced by at least 30 percent. | 12 months | 
| Survival | Overall survival (all-cause death) | 3 years, 5 years | 
| Adverse events | Treatment-related symptoms | 3 years, 5 years |