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

Ovarian Cancer Clinical Trial

Official title:

A Phase II Prospective Single-arm Clinical Study of Aribulin Combined With Carboplatin and Bevacizumab in the First-line Treatment of Platinum-sensitive Recurrent Ovarian Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05965141
• Other study ID #: 2022-LCYJ-YY01
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: August 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: April 2023
• Source: Second Affiliated Hospital of Guangzhou Medical University
• Contact: Jingqi Chen, MD
• Phone: 18928787238
• Email: chenjingqi2002[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Trial time plan: The inclusion time of the plan: 22 months. Planned trial duration: 24 months.

1. Experimental drugs: Aribrine mesylate injection, carboplatin, bevacizumab.

2. Administration regimen: Iribrine mesylate injection: 1.4mg/m2i.v. 30 min, d1 d8, every 21 days; Carboplatin: AUC=5~6 i.v. d1, every 21 days; Bevacizumab: 7.5mg/kg, i.v. 30-90 min,d1, every 21 days. The dose can be adjusted according to the state of the patient.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 38
• Est. completion date: June 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

• 18 years of age =75 years of female.

• Expected survival = 3 months.

Exclusion Criteria:

• Partial tumor related symptoms.

• Partial comorbidity.

• Subjects developed new secondary malignancies.

• other.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Guangzhou Medical University

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: ESMO Open. 2021 Apr;6(2):100097. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Disease control rate	Percentage of subjects who achieved PR, CR, and SD.	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	Progression-free survival time	The time between the patient's first treatment date and any recorded tumor progression or death from any cause.	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	Clinical benefit rate	Percentage of subjects who achieved PR, CR, and SD for at least 24 weeks.	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.