Aribulin Combined With Carboplatin and Bevacizumab in the Treatment of Ovarian Cancer

NCT05965141 | Unknown Phase 1

• 1 other identifier: 2022-LCYJ-YY01
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective phase II, single-center, single-arm clinical study of platinum-sensitive relapsed ovarian cancer. The main objective of this study is to evaluate the efficacy, safety and tolerability of Aribrine combined with carboplatin and bevacizumab in first-line treatment of platinum-sensitive relapsed ovarian cancer.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  The proportion of subjects who achieved PR and CR.

  During treatment, imaging examinations were performed ±3 days every 2 cycles and D0±1 days per cycle for CA-125. When the efficacy was evaluated as PR or CR, imaging was performed again at 6 weeks ±3 days.

Secondary Outcomes (3)

• Disease control rate

  During treatment, imaging examinations were performed ±3 days every 2 cycles and D0±1 days per cycle for CA-125. When the efficacy was evaluated as PR or CR, imaging was performed again at 6 weeks ±3 days.

• Progression-free survival time

  During treatment, imaging examinations were performed ±3 days every 2 cycles and D0±1 days per cycle for CA-125. When the efficacy was evaluated as PR or CR, imaging was performed again at 6 weeks ±3 days.

• Clinical benefit rate

  During treatment, imaging examinations were performed ±3 days every 2 cycles and D0±1 days per cycle for CA-125. When the efficacy was evaluated as PR or CR, imaging was performed again at 6 weeks ±3 days.

Study Arms (1)

Aribulin in combination with carboplatin and bevacizumab

EXPERIMENTAL

This is a one-arm study without randomization. There was only one trial group of Aribulin combined with carboplatin and bevacizumab.

Drug: Aribulin;carboplatin;bevacizumab

Interventions

Aribulin;carboplatin;bevacizumab DRUG

Aribulin combined with carboplatin and bevacizumab in first-line treatment of platinum-sensitive recurrent ovarian cancer.

Aribulin in combination with carboplatin and bevacizumab

Eligibility Criteria

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

You may qualify if:

• Patients with measurable or immeasurable disease (RECIST v1.1) or CA 125 evaluable disease (GCIG criteria) or histologically confirmed diagnosis of recurrent ovarian cancer.
• First disease recurrence after first-line platinum chemotherapy \>6 months.
• years of age ≤75 years of female.
• Expected survival ≥ 3 months.

You may not qualify if:

• Partial tumor related symptoms.
• Partial comorbidity.
• Subjects developed new secondary malignancies.
• other.

Sponsors & Collaborators

• Second Affiliated Hospital of Guangzhou Medical University: lead

Related Publications (16)

• Bray F, Ren JS, Masuyer E, Ferlay J. Global estimates of cancer prevalence for 27 sites in the adult population in 2008. Int J Cancer. 2013 Mar 1;132(5):1133-45. doi: 10.1002/ijc.27711. Epub 2012 Jul 26.

  PMID: 22752881 BACKGROUND

• Ramalingam P. Morphologic, Immunophenotypic, and Molecular Features of Epithelial Ovarian Cancer. Oncology (Williston Park). 2016 Feb;30(2):166-76.

  PMID: 26892153 BACKGROUND

• Paik ES, Lee YY, Lee EJ, Choi CH, Kim TJ, Lee JW, Bae DS, Kim BG. Survival analysis of revised 2013 FIGO staging classification of epithelial ovarian cancer and comparison with previous FIGO staging classification. Obstet Gynecol Sci. 2015 Mar;58(2):124-34. doi: 10.5468/ogs.2015.58.2.124. Epub 2015 Mar 16.

  PMID: 25798426 BACKGROUND

• Mahmood RD, Morgan RD, Edmondson RJ, Clamp AR, Jayson GC. First-Line Management of Advanced High-Grade Serous Ovarian Cancer. Curr Oncol Rep. 2020 Jun 4;22(6):64. doi: 10.1007/s11912-020-00933-8.

  PMID: 32494876 BACKGROUND

• Coleman RL, Brady MF, Herzog TJ, Sabbatini P, Armstrong DK, Walker JL, Kim BG, Fujiwara K, Tewari KS, O'Malley DM, Davidson SA, Rubin SC, DiSilvestro P, Basen-Engquist K, Huang H, Chan JK, Spirtos NM, Ashfaq R, Mannel RS. Bevacizumab and paclitaxel-carboplatin chemotherapy and secondary cytoreduction in recurrent, platinum-sensitive ovarian cancer (NRG Oncology/Gynecologic Oncology Group study GOG-0213): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Jun;18(6):779-791. doi: 10.1016/S1470-2045(17)30279-6. Epub 2017 Apr 21.

  PMID: 28438473 BACKGROUND

• Jordan MA, Wilson L. Microtubules as a target for anticancer drugs. Nat Rev Cancer. 2004 Apr;4(4):253-65. doi: 10.1038/nrc1317. No abstract available.

  PMID: 15057285 BACKGROUND

• Smith JA, Wilson L, Azarenko O, Zhu X, Lewis BM, Littlefield BA, Jordan MA. Eribulin binds at microtubule ends to a single site on tubulin to suppress dynamic instability. Biochemistry. 2010 Feb 16;49(6):1331-7. doi: 10.1021/bi901810u.

  PMID: 20030375 BACKGROUND

• Ito K, Hamamichi S, Abe T, Akagi T, Shirota H, Kawano S, Asano M, Asano O, Yokoi A, Matsui J, Umeda IO, Fujii H. Antitumor effects of eribulin depend on modulation of the tumor microenvironment by vascular remodeling in mouse models. Cancer Sci. 2017 Nov;108(11):2273-2280. doi: 10.1111/cas.13392. Epub 2017 Sep 22.

  PMID: 28869796 BACKGROUND

• Cortes J, Schoffski P, Littlefield BA. Multiple modes of action of eribulin mesylate: Emerging data and clinical implications. Cancer Treat Rev. 2018 Nov;70:190-198. doi: 10.1016/j.ctrv.2018.08.008. Epub 2018 Aug 21.

  PMID: 30243063 BACKGROUND

• Hensley ML, Kravetz S, Jia X, Iasonos A, Tew W, Pereira L, Sabbatini P, Whalen C, Aghajanian CA, Zarwan C, Berlin S. Eribulin mesylate (halichondrin B analog E7389) in platinum-resistant and platinum-sensitive ovarian cancer: a 2-cohort, phase 2 study. Cancer. 2012 May 1;118(9):2403-10. doi: 10.1002/cncr.26569. Epub 2011 Sep 20.

  PMID: 21935916 BACKGROUND

• Cortes J, O'Shaughnessy J, Loesch D, Blum JL, Vahdat LT, Petrakova K, Chollet P, Manikas A, Dieras V, Delozier T, Vladimirov V, Cardoso F, Koh H, Bougnoux P, Dutcus CE, Seegobin S, Mir D, Meneses N, Wanders J, Twelves C; EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389) investigators. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet. 2011 Mar 12;377(9769):914-23. doi: 10.1016/S0140-6736(11)60070-6. Epub 2011 Mar 2.

  PMID: 21376385 BACKGROUND

• Kaufman PA, Awada A, Twelves C, Yelle L, Perez EA, Velikova G, Olivo MS, He Y, Dutcus CE, Cortes J. Phase III open-label randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol. 2015 Feb 20;33(6):594-601. doi: 10.1200/JCO.2013.52.4892. Epub 2015 Jan 20.

  PMID: 25605862 BACKGROUND

• De Angelis C, Bruzzese D, Bernardo A, Baldini E, Leo L, Fabi A, Gamucci T, De Placido P, Poggio F, Russo S, Forestieri V, Lauria R, De Santo I, Michelotti A, Del Mastro L, De Laurentiis M, Giuliano M, De Placido S, Arpino G. Eribulin in combination with bevacizumab as second-line treatment for HER2-negative metastatic breast cancer progressing after first-line therapy with paclitaxel and bevacizumab: a multicenter, phase II, single arm trial (GIM11-BERGI). ESMO Open. 2021 Apr;6(2):100054. doi: 10.1016/j.esmoop.2021.100054. Epub 2021 Feb 16.

  PMID: 33601296 BACKGROUND

• Hardy-Bessard AC, Brocard F, Clatot F, Lortholary A, You B, Grenier J, Martin-Babau J, Lucas B, Meunier J, Ferrero JM, Savoye AM, Marti A, Despax R, Moullet I, Emile G. First-line bevacizumab and eribulin combination therapy for HER2-negative metastatic breast cancer: Efficacy and safety in the GINECO phase II ESMERALDA study. Breast. 2020 Dec;54:256-263. doi: 10.1016/j.breast.2020.09.011. Epub 2020 Sep 30.

  PMID: 33188992 BACKGROUND

• Yuan P, Hu X, Sun T, Li W, Zhang Q, Cui S, Cheng Y, Ouyang Q, Wang X, Chen Z, Hiraiwa M, Saito K, Funasaka S, Xu B. Eribulin mesilate versus vinorelbine in women with locally recurrent or metastatic breast cancer: A randomised clinical trial. Eur J Cancer. 2019 May;112:57-65. doi: 10.1016/j.ejca.2019.02.002. Epub 2019 Mar 29.

  PMID: 30928806 BACKGROUND

• Zhao Y, Xie N, Li W, Chen W, Lv Z, Zheng Y, Sun T, Liu J, Zhang J, Hu S, Wang Y, Gong C, Li Y, Xie Y, Ge R, Xu F, Wang B. Real-world effectiveness of eribulin in heavily pretreated patients with metastatic breast cancer in China: a multicenter retrospective study. Ther Adv Med Oncol. 2021 Jul 9;13:17588359211030210. doi: 10.1177/17588359211030210. eCollection 2021.

  PMID: 34290830 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; 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

Study Officials

• Jingqi Chen

  Principal Investigator

  STUDY CHAIR

Central Study Contacts

Jingqi Chen, MD

CONTACT

18928787238; chenjingqi2002@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2023
• First Posted: July 28, 2023
• Study Start: August 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share