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Bortezomib and Pegylated Liposomal Doxorubicin in BRCA Wild-type Platinum-resistant Recurrent Ovarian Cancer Patients

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ClinicalTrials.gov Identifier: NCT03509246
Recruitment Status : Unknown
Verified January 2020 by Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : April 26, 2018
Last Update Posted : January 14, 2020
Information provided by (Responsible Party):
Seoul National University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ovarian Neoplasm Epithelial High Grade Serous Carcinoma Drug: Pegylated liposomal doxorubicin plus Bortezomib Phase 2

Detailed Description:
Subjects are dosed with Bortezomib and PLD for a maximum of 6 cycles of 4 weeks. The response rate is evaluated with CT according to RECIST criteria ver 1.1. The efficacy and safety of the drug are assessed at the time of recurrence, at the time of death, or after 24 months after the end of the study drug administration.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 15, 2018
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Arm Intervention/treatment
Experimental: Pegylated liposomal doxorubicin plus Bortezomib combination
At BRCA wild-type platinum-resistant recurrent ovarian cancer patients, Pegylated liposomal doxorubicin and Bortezomib combination therapy for six cycles.
Drug: Pegylated liposomal doxorubicin plus Bortezomib
Pegylated liposomal doxorubicin 40mg/m2 subcutaneous for 60 - 90 minutes at day 4 plus Bortezomib 1.3mg/m2 subcutaneous injection at day 1,4,8,11 for 6 cycles

Primary Outcome Measures :
  1. Overall response rate [ Time Frame: up to 6yr ]
    In the modified ITT group, the response rate to combination therapy with bortezomib and PLD 2

  2. Partial response rate [ Time Frame: up to 6yr ]
    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.

Secondary Outcome Measures :
  1. Complete remission rate [ Time Frame: up to 6yr ]
    The proportion of subjects who had a confirmed complete response according to RECIST criteria version 1.1 in the modified ITT analysis group

  2. Progression-free survival [ Time Frame: up to 2yr ]
    Patients who have recurred disease after the end of the administration are identified and measured.

  3. Overall survival [ Time Frame: up to 6yr ]
    Patients who died from illness after the start of treatment were identified and measured.

  4. Response period [ Time Frame: up to 5yr ]
    duration of objective response period

  5. Quality of life [ Time Frame: up to 6yr ]
    Evaluation via Physicians Global Assessment to measure the quality of life and pain descriptive diary.

  6. Adverse drug reactions [ Time Frame: up to 6yr ]
    To be evaluated according to NCI CTCAE version 4.03 Frequency of occurrence of each drug adverse reaction and 95% confidence interval, grade 3 or higher, the frequency of adverse drug events and 95% confidence interval.

  7. Genetic susceptibility assessment [ Time Frame: up to 6yr ]
    Response rate in subjects with CCNE1 amplification.

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03509246

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Contact: Kidong Kim 82-31-787-7262 kidong.kim.md@gmail.com

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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam Si, Gyenggi DO, Korea, Republic of, 463707
Contact: KIDONG KIM, MD    82-31-787-7262    KIDONG.KIM.MD@GMAIL.COM   
Principal Investigator: KIDONG KIM, MD         
Sponsors and Collaborators
Seoul National University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03509246    
Other Study ID Numbers: EBLIN
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Ovarian Neoplasms
Cystadenocarcinoma, Serous
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Cystic, Mucinous, and Serous
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action