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

NCT05737303 | Recruiting Phase 3 DMC

• 1 other identifier: IRB-20230058-R
• Study Type: interventional
• Target: 538
• Locations: 1 country
• Sites: 11

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Disease progression as first failure

  20 months

Secondary Outcomes (3)

• Objective Remission Rate

  12 months

• Survival

  3 years, 5 years

• Adverse events

  3 years, 5 years

Study Arms (2)

Nab-Paclitaxel/carboplatin for systemic therapy after surgery

EXPERIMENTAL

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

Paclitaxel/carboplatin for systemic therapy

ACTIVE COMPARATOR

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

Interventions

nab-paclitaxel combined with carboplatin DRUG

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)

Also known as: paclitaxel combined with carboplatin

Nab-Paclitaxel/carboplatin for systemic therapy after surgery; Paclitaxel/carboplatin for systemic therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (11)

Sun Yat-Sen University Cancer Hospital

Guangzhou, Guangdong, China

NOT YET RECRUITING

Qilu Hospital of Shandong University

Ji'nan, Shandong, 250012, China

NOT YET RECRUITING

Yaxia Chen

Hangzhou, Zhejiang, 310006, China

RECRUITING

Sir Run Run Hospital

Hangzhou, Zhejiang, China

NOT YET RECRUITING

The First Affiliated Hospital of Medical College of Zhejiang University

Hangzhou, Zhejiang, China

NOT YET RECRUITING

The Second Affiliated Hospital of Medical College of Zhejiang University

Hangzhou, Zhejiang, China

NOT YET RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

NOT YET RECRUITING

Ningbo women's and children's Hospital

Ningbo, Zhejiang, China

NOT YET RECRUITING

The No, 1 People's Hospital of Ningbo

Ningbo, Zhejiang, China

NOT YET RECRUITING

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

NOT YET RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

NOT YET RECRUITING

Related Publications (12)

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

  PMID: 33538338 BACKGROUND

• Zheng L, Cui C, Shi O, Lu X, Li YK, Wang W, Li Y, Wang Q. Incidence and mortality of ovarian cancer at the global, regional, and national levels, 1990-2017. Gynecol Oncol. 2020 Oct;159(1):239-247. doi: 10.1016/j.ygyno.2020.07.008. Epub 2020 Jul 18.

  PMID: 32690392 BACKGROUND

• Zeighami S, Soltani M, Khajeh F, Ariafar A, Naghdi-Sedeh N. Testicular papillary serous carcinoma of ovarian type, a rare case report, however an important timely diagnostic issue. Urol Case Rep. 2020 Jun 16;33:101301. doi: 10.1016/j.eucr.2020.101301. eCollection 2020 Nov.

  PMID: 33102004 BACKGROUND

• Dueckelmann AM, Fink D, Harter P, Heinzelmann V, Marth C, Mueller M, Reinthaller A, Tamussino K, Wimberger P, Sehouli J. The use of PIPAC (pressurized intraperitoneal aerosol chemotherapy) in gynecological oncology: a statement by the "Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom (AGO-OVAR)", the Swiss and Austrian AGO, and the North-Eastern German Society of Gynaecologic Oncology. Arch Gynecol Obstet. 2018 Apr;297(4):837-846. doi: 10.1007/s00404-018-4673-0. Epub 2018 Jan 22.

  PMID: 29356953 BACKGROUND

• Perez-Fidalgo JA, Grau F, Farinas L, Oaknin A. Systemic treatment of newly diagnosed advanced epithelial ovarian cancer: From chemotherapy to precision medicine. Crit Rev Oncol Hematol. 2021 Feb;158:103209. doi: 10.1016/j.critrevonc.2020.103209. Epub 2020 Dec 31.

  PMID: 33388455 BACKGROUND

• Huang CY, Cheng M, Lee NR, Huang HY, Lee WL, Chang WH, Wang PH. Comparing Paclitaxel-Carboplatin with Paclitaxel-Cisplatin as the Front-Line Chemotherapy for Patients with FIGO IIIC Serous-Type Tubo-Ovarian Cancer. Int J Environ Res Public Health. 2020 Mar 26;17(7):2213. doi: 10.3390/ijerph17072213.

  PMID: 32224896 BACKGROUND

• Ozols RF, Bundy BN, Greer BE, Fowler JM, Clarke-Pearson D, Burger RA, Mannel RS, DeGeest K, Hartenbach EM, Baergen R; Gynecologic Oncology Group. Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: a Gynecologic Oncology Group study. J Clin Oncol. 2003 Sep 1;21(17):3194-200. doi: 10.1200/JCO.2003.02.153. Epub 2003 Jul 14.

  PMID: 12860964 BACKGROUND

• Ratanajarusiri T, Sriuranpong V, Sitthideatphaiboon P, Poovoravan N, Vinayanuwat C, Parinyanitikul N, Angspatt P, Thawinwisan W, Tanasanvimon S. A Difference in the Incidences of Hypersensitivity Reactions to Original and Generic Taxanes. Chemotherapy. 2017;62(2):134-139. doi: 10.1159/000450748. Epub 2016 Dec 20.

  PMID: 27997900 BACKGROUND

• Kundranda MN, Niu J. Albumin-bound paclitaxel in solid tumors: clinical development and future directions. Drug Des Devel Ther. 2015 Jul 24;9:3767-77. doi: 10.2147/DDDT.S88023. eCollection 2015.

  PMID: 26244011 BACKGROUND

• du Bois A, Quinn M, Thigpen T, Vermorken J, Avall-Lundqvist E, Bookman M, Bowtell D, Brady M, Casado A, Cervantes A, Eisenhauer E, Friedlaender M, Fujiwara K, Grenman S, Guastalla JP, Harper P, Hogberg T, Kaye S, Kitchener H, Kristensen G, Mannel R, Meier W, Miller B, Neijt JP, Oza A, Ozols R, Parmar M, Pecorelli S, Pfisterer J, Poveda A, Provencher D, Pujade-Lauraine E, Randall M, Rochon J, Rustin G, Sagae S, Stehman F, Stuart G, Trimble E, Vasey P, Vergote I, Verheijen R, Wagner U; Gynecologic Cancer Intergroup; AGO-OVAR; ANZGOG; EORTC; GEICO; GINECO; GOG; JGOG; MRC/NCRI; NCIC-CTG; NCI-US; NSGO; RTOG; SGCTG; IGCS; Organizational team of the two prior International OCCC. 2004 consensus statements on the management of ovarian cancer: final document of the 3rd International Gynecologic Cancer Intergroup Ovarian Cancer Consensus Conference (GCIG OCCC 2004). Ann Oncol. 2005;16 Suppl 8:viii7-viii12. doi: 10.1093/annonc/mdi961. No abstract available.

  PMID: 16239238 BACKGROUND

• Wang H, Fan L, Wu X, Han Y. Efficacy evaluation of albumin-bound paclitaxel combined with carboplatin as neoadjuvant chemotherapy for primary epithelial ovarian cancer. BMC Womens Health. 2022 Jun 11;22(1):224. doi: 10.1186/s12905-022-01794-y.

  PMID: 35690772 BACKGROUND

• Teneriello MG, Tseng PC, Crozier M, Encarnacion C, Hancock K, Messing MJ, Boehm KA, Williams A, Asmar L. Phase II evaluation of nanoparticle albumin-bound paclitaxel in platinum-sensitive patients with recurrent ovarian, peritoneal, or fallopian tube cancer. J Clin Oncol. 2009 Mar 20;27(9):1426-31. doi: 10.1200/JCO.2008.18.9548. Epub 2009 Feb 17.

  PMID: 19224848 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms

Interventions

Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Yaxia Chen, MD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaxia Chen, MD

CONTACT

+86-571-87061501; chenyax@zju.edu.cn

Yang Li, MD

CONTACT

+86-571-87061501; li_yang@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2023
• First Posted: February 21, 2023
• Study Start: November 27, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 11, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (11)