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

  • STATUS
    Recruiting
  • End date
    Mar 24, 2022
  • participants needed
    44
  • sponsor
    Seoul National University Hospital
Updated on 24 January 2021

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.

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.

Details
Condition Ovarian Neoplasm Epithelial, High Grade Serous Carcinoma
Treatment Pegylated liposomal doxorubicin plus Bortezomib
Clinical Study IdentifierNCT03509246
SponsorSeoul National University Hospital
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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