Clinical trial · Interventional
Bortezomib and Pegylated Liposomal Doxorubicin in BRCA Wild-type Platinum-resistant Recurrent Ovarian Cancer Patients
A Phase II Trial to Evaluate the Efficacy of Bortezomib and Pegylated Liposomal Doxorubicin in Patients With BRCA Wild-type Platinum-resistant Recurrent Ovarian Cancer
NCT03509246CI-TRIAL-00042788unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a phase II clinical trial to evaluate the safety and efficacy of Bortezomib plus Pegylated liposomal doxorubicin combination therapy in a histologic type of high-grade serous carcinoma without BRCA mutation among patients with platinum-resistant recurrent ovarian cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High Grade Serous Carcinoma | — | UNRESOLVED | — |
| Ovarian Neoplasm Epithelial | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pegylated liposomal doxorubicin plus Bortezomib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pegylated liposomal doxorubicin plus Bortezomib combination
- description
- At BRCA wild-type platinum-resistant recurrent ovarian cancer patients, Pegylated liposomal doxorubicin and Bortezomib combination therapy for six cycles.
- interventionNames
- Drug: Pegylated liposomal doxorubicin plus Bortezomib
Primary outcomes (2)
- measure
- Overall response rate
- timeFrame
- up to 6yr
- description
- In the modified ITT group, the response rate to combination therapy with bortezomib and PLD 2
- measure
- Partial response rate
- timeFrame
- up to 6yr
- description
- The percentage of patients who received a confirmed treatment response over a partial response according to the RECIST criteria version 1.1 in the modified ITT analysis group. The evaluation is based on the researchers of each participating organization.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Patients diagnosed with epithelial ovarian cancer, fallopian tube cancer, or peritoneal cancer based on histologic findings obtained from biopsy/surgery and having a histologic type of high-grade serous cancer. * In the absence of a mutation of the BRCA gene (no germline mutation should be identified, not in the case of a somatic mutation) * Recurrence within 6 months after platinum-based chemotherapy. * ECOG performance 2 points or less. * Blood tests performed within 2 weeks of enrollment meet the following results: Neutrophil \> 1,500/mm3; Platelet \> 100,000/mm3; Hemoglobin \> 9.0 g/dL; Total bilirubin \< 1.5 x upper limit of normal (ULN); AST/ALT \< 3.0 x ULN (or \< 5 x ULM in case of liver metastases); Creatinine \< 1.5 x ULN; Electrolytes should be within normal limits. * Patients who understand the content of the study description and voluntarily agree in writing. * Patients who are willing and able to adhere to the visit schedule, treatment plan, laboratory tests, and other testing procedures. Exclusion Criteria: * Patients previously treated with three or more anticancer regimens. Maintenance therapy is not considered a separate regimen (eg\> paclitaxel-carboplatin-bevacizumab therapy). In the combined chemotherapy, when one drug is subtracted due to toxicity, the regimen is not counted as a change (Eg\> paclitaxel-carboplatin chemotherapy, paclitaxel was discontinued due to neurotoxicity and carboplatin alone was not considered as a change of regimen). * Previous refractory to ovarian cancer chemotherapy. * Patients diagnosed with other tumors other than ovarian cancer for the last 5 years (not CIS). * pregnant woman. * Patients with uncontrolled infection. * In the case of congenital immune disease or acquired immune deficiency syndrome. * Women in lactation. * History with Grade 3 or higher peripheral neuropathy. * History of hypersensitivity reactions to PLD or bortezomib. * If the physician is judged to have any serious illness or medical condition for which the patient is not suitable for the study. * Patients with confirmed BRCA somatic mutations. * Patients with acute diffuse infiltrative lung disease and cardiovascular disease.
References
Publications (5)
- BACKGROUNDOrlowski RZ, Nagler A, Sonneveld P, Blade J, Hajek R, Spencer A, San Miguel J, Robak T, Dmoszynska A, Horvath N, Spicka I, Sutherland HJ, Suvorov AN, Zhuang SH, Parekh T, Xiu L, Yuan Z, Rackoff W, Harousseau JL. Randomized phase III study of pegylated liposomal doxorubicin plus bortezomib compared with bortezomib alone in relapsed or refractory multiple myeloma: combination therapy improves time to progression. J Clin Oncol. 2007 Sep 1;25(25):3892-901. doi: 10.1200/JCO.2006.10.5460. Epub 2007 Aug 6. PMID 17679727
- BACKGROUNDEtemadmoghadam D, Weir BA, Au-Yeung G, Alsop K, Mitchell G, George J; Australian Ovarian Cancer Study Group; Davis S, D'Andrea AD, Simpson K, Hahn WC, Bowtell DD. Synthetic lethality between CCNE1 amplification and loss of BRCA1. Proc Natl Acad Sci U S A. 2013 Nov 26;110(48):19489-94. doi: 10.1073/pnas.1314302110. Epub 2013 Nov 11. PMID 24218601
- BACKGROUNDKim G, Ison G, McKee AE, Zhang H, Tang S, Gwise T, Sridhara R, Lee E, Tzou A, Philip R, Chiu HJ, Ricks TK, Palmby T, Russell AM, Ladouceur G, Pfuma E, Li H, Zhao L, Liu Q, Venugopal R, Ibrahim A, Pazdur R. FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy. Clin Cancer Res. 2015 Oct 1;21(19):4257-61. doi: 10.1158/1078-0432.CCR-15-0887. Epub 2015 Jul 17. PMID 26187614
- BACKGROUNDCancer Genome Atlas Research Network. Integrated genomic analyses of ovarian carcinoma. Nature. 2011 Jun 29;474(7353):609-15. doi: 10.1038/nature10166. PMID 21720365
- DERIVEDLee YJ, Seol A, Lee M, Kim JW, Kim HS, Kim K, Suh DH, Kim S, Kim SW, Lee JY. A Phase II Trial to Evaluate the Efficacy of Bortezomib and Liposomal Doxorubicin in Patients With BRCA Wild-type Platinum-resistant Recurrent Ovarian Cancer (KGOG 3044/EBLIN). In Vivo. 2022 Jul-Aug;36(4):1949-1958. doi: 10.21873/invivo.12917. PMID 35738633