Bortezomib and Pegylated Liposomal Doxorubicin in BRCA Wild-type Platinum-resistant Recurrent Ovarian Cancer Patients
- Conditions
- Ovarian Neoplasm EpithelialHigh Grade Serous Carcinoma
- Interventions
- Drug: Pegylated liposomal doxorubicin plus Bortezomib
- Registration Number
- NCT03509246
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 44
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pegylated liposomal doxorubicin plus Bortezomib combination Pegylated liposomal doxorubicin plus Bortezomib At BRCA wild-type platinum-resistant recurrent ovarian cancer patients, Pegylated liposomal doxorubicin and Bortezomib combination therapy for six cycles.
- Primary Outcome Measures
Name Time Method Overall response rate up to 6yr In the modified ITT group, the response rate to combination therapy with bortezomib and PLD 2
Partial response rate 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
Name Time Method Complete remission rate 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
Progression-free survival up to 2yr Patients who have recurred disease after the end of the administration are identified and measured.
Adverse drug reactions 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.
Genetic susceptibility assessment up to 6yr Response rate in subjects with CCNE1 amplification.
Overall survival up to 6yr Patients who died from illness after the start of treatment were identified and measured.
Response period up to 5yr duration of objective response period
Quality of life up to 6yr Evaluation via Physicians Global Assessment to measure the quality of life and pain descriptive diary.
Trial Locations
- Locations (1)
Seoul National University Bundang Hospital
🇰🇷Seongnam Si, Gyenggi DO, Korea, Republic of