Description:
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.
Title
- Brief Title: Bortezomib and Pegylated Liposomal Doxorubicin in BRCA Wild-type Platinum-resistant Recurrent Ovarian Cancer Patients
- 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
Clinical Trial IDs
- ORG STUDY ID:
EBLIN
- NCT ID:
NCT03509246
Conditions
- Ovarian Neoplasm Epithelial
- High Grade Serous Carcinoma
Interventions
Drug | Synonyms | Arms |
---|
Pegylated liposomal doxorubicin plus Bortezomib | | Pegylated liposomal doxorubicin plus Bortezomib combination |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Pegylated liposomal doxorubicin plus Bortezomib combination | Experimental | At BRCA wild-type platinum-resistant recurrent ovarian cancer patients, Pegylated liposomal doxorubicin and Bortezomib combination therapy for six cycles. | - Pegylated liposomal doxorubicin plus Bortezomib
|
Eligibility 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 19 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Overall response rate |
Time Frame: | up to 6yr |
Safety Issue: | |
Description: | In the modified ITT group, the response rate to combination therapy with bortezomib and PLD 2 |
Secondary Outcome Measures
Measure: | Complete remission rate |
Time Frame: | up to 6yr |
Safety Issue: | |
Description: | The proportion of subjects who had a confirmed complete response according to RECIST criteria version 1.1 in the modified ITT analysis group |
Measure: | Progression-free survival |
Time Frame: | up to 2yr |
Safety Issue: | |
Description: | Patients who have recurred disease after the end of the administration are identified and measured. |
Measure: | Overall survival |
Time Frame: | up to 6yr |
Safety Issue: | |
Description: | Patients who died from illness after the start of treatment were identified and measured. |
Measure: | Response period |
Time Frame: | up to 5yr |
Safety Issue: | |
Description: | duration of objective response period |
Measure: | Quality of life |
Time Frame: | up to 6yr |
Safety Issue: | |
Description: | Evaluation via Physicians Global Assessment to measure the quality of life and pain descriptive diary. |
Measure: | Adverse drug reactions |
Time Frame: | up to 6yr |
Safety Issue: | |
Description: | 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. |
Measure: | Genetic susceptibility assessment |
Time Frame: | up to 6yr |
Safety Issue: | |
Description: | Response rate in subjects with CCNE1 amplification. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Seoul National University Hospital |
Last Updated
January 14, 2020