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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
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
Seoul National University Bundang Hospital
Seongnam-si, Gyenggi DO, South Korea
RECRUITINGOverall response rate
In the modified ITT group, the response rate to combination therapy with bortezomib and PLD 2
Time frame: up to 6yr
Partial response rate
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.
Time frame: up to 6yr
Complete remission rate
The proportion of subjects who had a confirmed complete response according to RECIST criteria version 1.1 in the modified ITT analysis group
Time frame: up to 6yr
Progression-free survival
Patients who have recurred disease after the end of the administration are identified and measured.
Time frame: up to 2yr
Overall survival
Patients who died from illness after the start of treatment were identified and measured.
Time frame: up to 6yr
Response period
duration of objective response period
Time frame: up to 5yr
Quality of life
Evaluation via Physicians Global Assessment to measure the quality of life and pain descriptive diary.
Time frame: up to 6yr
Adverse drug reactions
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.
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Time frame: up to 6yr
Genetic susceptibility assessment
Response rate in subjects with CCNE1 amplification.
Time frame: up to 6yr