Effect of Albumin-bound Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Patients Receiving Neoadjuvant Chemotherapy for Advanced Ovarian, Fallopian Tube or Peritoneal Cancer: A Phase 2 Single Center Clinical Trial

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05316376
• Collaborator: (none)
• Enrollment: 78
• Arms: 2
• Anticipated Duration (Months): 36

Study Details

Study Description

Brief Summary

Neoadjuvant chemotherapy (NACT) is an important option for patients with advanced ovarian cancer. Paclitaxel plus carboplatin is the first-line regimen for ovarian cancer NACT patients. However, the efficacy of NACT is controversial, how to improve the efficacy become an urgent problem to be solved in the treatment of ovarian cancer. It has been confirmed that the dose-intensive paclitaxel combined carboplatin regimen can improve the prognosis in Asian patients with advanced ovarian cancer. However, this protocol has a low rate of complete tumor remission after NACT (4%) with toxicities and high probability of severe hypersensitivity reactions. Albumin-bound paclitaxel has the characteristics of tumor targeting, low allergenicity. We propose that dose-dense albumin-bound paclitaxel (ddnab-paclitaxel) (100 mg/m2, days 1, 8, and 15) combined with carboplatin (AUC = 5 days 1, 4 weeks) regimen may be superior to the paclitaxel plus carboplatin regimen. We conducted this Phase II randomized controlled study to testify the efficacy of dd-nab paclitaxel. 57 stage IIIC-IV patients with high-grade epithelial, fallopian tube, and peritoneal cancer who are unable to undergo optimal cytoreduction and receive NACT after tumor biopsy will be recruited. The regimen for the study group is albumin-bound paclitaxel (100 mg/m2, days 1, 8, and 15 doses) combined with carboplatin (AUC = 5 day 1, 4 weeks), while patients in the control group use paclitaxel (175 mg/m2, day 1) combined with carboplatin (AUC=6, day1). Interval debulking surgery(IDS) will be performed within 3-4 weeks after 3 cycles of NACT. The primary endpoint is the proportion of Chemotherapy Response Score (CRS) of 3 according to the CRS system. The secondary endpoints are progression-free survival(PFS), overall survival(OS) and the rates of complete resection and adverse events(AEs).

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer	Drug: albumin-bound paclitaxel; Drug: paclitaxel	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Dd-nab-paclitaxel (100 mg/m2, days 1, 8, and 15, every 4 weeks), combined with carboplatin (AUC = 5, days 1), dd-nab TC regimen every 4 weeks will be given to the patients in study group, while for the patients in control group, paclitaxel (175 mg/m2, day 1) combined with carboplatin (AUC=6, day1) will administered.Dd-nab-paclitaxel (100 mg/m2, days 1, 8, and 15, every 4 weeks), combined with carboplatin (AUC = 5, days 1), dd-nab TC regimen every 4 weeks will be given to the patients in study group, while for the patients in control group, paclitaxel (175 mg/m2, day 1) combined with carboplatin (AUC=6, day1) will administered.
• Masking: Single (Investigator)
• Masking Description: Pathological slides of omentum will be independently reviewed by two pathologists who will be blinded to the randomization to determine the CRS.
• Primary Purpose: Treatment
• Official Title: Effect of Albumin-bound Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Patients Receiving Neoadjuvant Chemotherapy for Advanced Ovarian, Fallopian Tube or Peritoneal Cancer: A Phase 2 Single Center Clinical Trial
• Anticipated Study Start Date: May 1, 2022
• Anticipated Primary Completion Date: Oct 30, 2023
• Anticipated Study Completion Date: Apr 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: dd-nabTC albumin-bound paclitaxel (100 mg/m2, days 1, 8, and 15, every 4 weeks) combined with carboplatin (AUC = 5, day 1, every 4 weeks)	Drug: albumin-bound paclitaxel; albumin-bound paclitaxel (100 mg/m2, days 1, 8, and 15, every 4 weeks) combined with carboplatin (AUC = 5 day 1, every 4 weeks)
Active Comparator: CONTROL paclitaxel (175 mg/m2, day 1, every 4 weeks) combined with carboplatin (AUC=6, day1, every 4 weeks)	Drug: paclitaxel; paclitaxel (175 mg/m2, day 1, every 3 weeks) combined with carboplatin (AUC=6, day1, every 3 weeks)

Outcome Measures

Primary Outcome Measures

1. chemotherapy response score(CRS) 3 [At the end of cycle 3 NACT (each cycle is 21 days)]

   the proportion of chemotherapy response score 3

Secondary Outcome Measures

1. PFS [From date of randomization until the date of first documented progression, assessed up to 3 years]

   progression-free survival

2. OS [From date of randomization until the time of death from any cause, assessed up to 3 years]

   overall survival

3. AEs [during the treatment procedure]

   adverse effects of chemotherapy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• International Federation of Gynecology and Obstetrics(FIGO) stage IIIC-IVA, HGSOC Patients with Fagotti score ≥8

• Adequate kidney function (blood creatinine 58-96 µmol/L)

• Adequate haematological function (haemoglobin ≥110g/L, leucocytes ≥4.0×109/L, neutrophils ≥2.0×109/L, platelets≥100×109/L)

• Adequate liver function (serum total bilirubin 3.4-22.2µmol/L, alanine aminotransferase (ALT) 7-40U/L, aspartate aminotransferase (AST) 13-35U/L, AST/ALT ≤1.5)

• World Health Organization(WHO) score 0-2

• expected lifespan>12 weeks

Exclusion Criteria:

• Patients who had received chemotherapy, radiotherapy or any kind of targeted therapy

• Complicated with any other known malignancies

• Patients with poor cardiopulmonary function, which would limit compliance with study requirements

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• ClinicalTrials.gov Identifier: NCT05316376
• Other Study ID Numbers: 2020-KY-036
• First Posted: Apr 7, 2022
• Last Update Posted: Apr 7, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel

Study Results

No Results Posted as of Apr 7, 2022