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

Sponsor

Women's Hospital School Of Medicine Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05737303

Collaborator

Jiaxing Maternity and Child Health Care Hospital (Other), Zhejiang University (Other), Second Affiliated Hospital, School of Medicine, Zhejiang University (Other), First Affiliated Hospital of Wenzhou Medical University (Other), Second Affiliated Hospital of Wenzhou Medical University (Other), Sun Yat-sen University (Other), Qilu Hospital of Shandong University (Other), Ningbo No. 1 Hospital (Other), Ningbo Women & Children's Hospital (Other), Sir Run Run Shaw Hospital (Other)

538

Enrollment

Locations

Arms

58.2

Anticipated Duration (Months)

48.9

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Drug: nab-paclitaxel combined with carboplatin	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

538 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Feb 24, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nab-Paclitaxel/carboplatin for systemic therapy after surgery 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 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) Other Names: paclitaxel combined with carboplatin
Active Comparator: Paclitaxel/carboplatin for systemic therapy 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 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) Other Names: paclitaxel combined with carboplatin

Arm

Intervention/Treatment

Experimental: Nab-Paclitaxel/carboplatin for systemic therapy after surgery

Drug: nab-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)

Other Names:

paclitaxel combined with carboplatin

Active Comparator: Paclitaxel/carboplatin for systemic therapy

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

Other Names:

paclitaxel combined with carboplatin

Outcome Measures

Primary Outcome Measures

Progression Free Survival [20 months]
Disease progression as first failure

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sun Yat-Sen University Cancer Hospital	Guangzhou	Guangdong	China
2	Qilu Hospital of Shandong University	Ji'nan	Shandong	China	250012
3	Yaxia Chen	Hangzhou	Zhejiang	China	310006
4	Sir Run Run Hospital	Hangzhou	Zhejiang	China
5	The First Affiliated Hospital of Medical College of Zhejiang University	Hangzhou	Zhejiang	China
6	The Second Affiliated Hospital of Medical College of Zhejiang University	Hangzhou	Zhejiang	China
7	Zhejiang Cancer Hospital	Hangzhou	Zhejiang	China
8	Ningbo women's and children's Hospital	Ningbo	Zhejiang	China
9	The No, 1 People's Hospital of Ningbo	Ningbo	Zhejiang	China
10	The Second Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang	China
11	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou		China