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

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Bortezomib; Doxorubicin; Liposomal doxorubicin

Criteria

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.