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.
- Conditions
- Neoplasms
- Registration Number
- KCT0003266
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief Summary
The KGOG3044_EBLIN study was completed early after 23 patients were registered by slowaccrual. The follow-up of median was 29.5 months, and the objective response rate was 8.7% (2/23). two patients to partial ducts The sun was observed. The median reaction period was 10.5 months, and the median non-progressive survival was 2.9 months. Treatment-related side effects of 3/4 grade were reported in 4.5 percent of patients. 1 with treatment-related side effects The life patient stopped treatment, and no treatment-related side effects were observed in the 4/5 class. family of TP53 CDK12 mutations were found in 67% (14/21) and 24% (12/21) of patients, respectively. partial tube resolution Inheritance associated with deficiency of homologous recombinant pathway in two patients with Boyne, including BRCA2, ATM and CDK12. A mutation in the ruler was observed. The combination of bortezomib and PLD has no particular side effects reported. However, the anti-tumor activity was not sufficient for ovarian cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 23
(1) over 19 years old
(2) Based on biopsy and surgical findings,Patients with epithelial ovarian cancer, carcinoma of the fallopian tube, or peritoneal cancer, with histologic type of high-grade serous cancer.
(3) there is no mutation in the Breast Cancer gene test
(it should be confirmed that there is no germline mutation, not necessarily in case of somatic mutation)
(4) recurrence within 6 months after platinum-based chemotherapy
(5) Eastern Cooperative Oncology Group performance 2 points or less
(6) Blood tests performed within 2 weeks of enrollment meet the following results.
A. Neutrophil > 1,500/mm3
B. Platelet > 100,000/mm3
C. Hemoglobin > 9.0 g/dL
D. Total bilirubin < 1.5 x upper limit of normal (ULN)
E. AST[aspartate aminotransferase] /ALT [alanine aminotransferase] < 3.0 x upper limit of normal (ULN) (or < 5 x upper limit of normal (ULN) in case of liver metastases)
F. Creatinine < 1.5 x upper limit of normal (ULN)
G. Electrolytes should be within normal limits.
(7) The patient understands the Inform concent form and voluntarily agrees in writing.
(8) The patient should observe visit schedules, treatment plans, laboratory tests and other testing procedures.
(1) The patient has previously been treated with more than three chemotheraphy(regimen). Maintenance Therapy is not counted as a separate regimen (example> paclitaxel carboplatin bevacizumab therapy).In the case of combined chemotherapy, subtraction of one drug due to toxicity is not counted as a change of regimen(example>if paclitaxel is discontinued due to neurotoxicity during the course of paclitaxel carboplatin chemotherapy and only carboplatin is administered, this is not considered a regimen change)
(2) Previously refractory to ovarian cancer chemotherapy
(3) If the patient has been diagnosed with other tumors other than ovarian cancer in the last 5 years (not Carcinoma in situ)
(4) Pregnant woman
(5) If the patient has an uncontrolled infection
(6) If the patient has a congenital immune disease or acquired immunodeficiency syndrome
(7) Women in lactation
(8) If the patient has Grade 3 or greater peripheral neuropathy
(9) If the patient has a history of hypersensitivity reaction to Pegylated liposomal doxorubicin or bortezomib
(10) If the investigator determines that the patient has a serious illness or medical condition
that is not appropriate for the study
(11) If it is confirmed that there is a Breast Cancer somatic mutation
(12) Patients with Acute Diffuse Invasive Pulmonary Disease and pericarduum Disease
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall response rate
- Secondary Outcome Measures
Name Time Method progression-free survival;overall survival;quality of life assessment score;Adverse Events