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

February 9, 2025 updated by: Women's Hospital School Of Medicine Zhejiang University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

538

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Wenzhou, China
        • Not yet recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
          • Xiaojian Yan
    • Guangdong
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • Sun Yat-sen University Cancer Hospital
        • Contact:
          • Jihong Liu
        • Contact:
          • Yanling Feng
    • Shandong
      • Ji'nan, Shandong, China, 250012
        • Not yet recruiting
        • Qilu Hospital of Shandong University
        • Contact:
        • Contact:
          • Beihua Kong
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Not yet recruiting
        • Zhejiang Cancer Hospital
        • Contact:
          • Yaqing Chen
      • Hangzhou, Zhejiang, China, 310006
        • Recruiting
        • Yaxia Chen
        • Contact:
        • Contact:
          • Yaxia Chen
      • Hangzhou, Zhejiang, China
        • Not yet recruiting
        • Sir Run Run Hospital
        • Contact:
          • Jianhua Yang
      • Hangzhou, Zhejiang, China
        • Not yet recruiting
        • The first affiliated hospital of medical college of zhejiang university
        • Contact:
          • Jianhua Qian
      • Hangzhou, Zhejiang, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Medical College of Zhejiang University
        • Contact:
          • Jianwei Zhou
      • Ningbo, Zhejiang, China
        • Not yet recruiting
        • Ningbo Women's and Children's Hospital
        • Contact:
          • Lingjun Zhao
      • Ningbo, Zhejiang, China
        • Not yet recruiting
        • The No, 1 People's Hospital of Ningbo
        • Contact:
          • Yutao Guan
      • Wenzhou, Zhejiang, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Wenzhou Medical University
        • Contact:
          • Yan Hu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Women's Hospital School Of Medicine Zhejiang University

Collaborators

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

Investigators

  • Principal Investigator: Yaxia Chen, MD, Study Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 2, 2023

First Submitted That Met QC Criteria

February 19, 2023

First Posted (Actual)

February 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 9, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-20230058-R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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