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

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ClinicalTrials.gov Identifier: NCT03509246
Recruitment Status : Recruiting
First Posted : April 26, 2018
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE March 29, 2018
First Posted Date  ICMJE April 26, 2018
Last Update Posted Date January 14, 2020
Actual Study Start Date  ICMJE May 15, 2018
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2018)
  • Overall response rate [ Time Frame: up to 6yr ]
    In the modified ITT group, the response rate to combination therapy with bortezomib and PLD 2
  • Partial response rate [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 1, 2019)
  • Complete remission rate [ Time Frame: 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 [ Time Frame: up to 2yr ]
    Patients who have recurred disease after the end of the administration are identified and measured.
  • Overall survival [ Time Frame: up to 6yr ]
    Patients who died from illness after the start of treatment were identified and measured.
  • Response period [ Time Frame: up to 5yr ]
    duration of objective response period
  • Quality of life [ Time Frame: up to 6yr ]
    Evaluation via Physicians Global Assessment to measure the quality of life and pain descriptive diary.
  • Adverse drug reactions [ Time Frame: 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 [ Time Frame: up to 6yr ]
    Response rate in subjects with CCNE1 amplification.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2018)
  • Complete remission rate [ Time Frame: 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 [ Time Frame: up to 2yr ]
    Patients who have recurred disease after the end of the administration are identified and measured.
  • Overall survival [ Time Frame: up to 6yr ]
    Patients who died from illness after the start of treatment were identified and measured.
  • Response period [ Time Frame: up to 5yr ]
    duration of objective response period
  • Quality of life [ Time Frame: up to 6yr ]
    Evaluation via Physicians Global Assessment to measure quality of life and pain descriptive diary.
  • Adverse drug reactions [ Time Frame: 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, frequency of drug adverse events and 95% confidence interval.
  • Genetic susceptibility assessment [ Time Frame: up to 6yr ]
    Response rate in subjects with CCNE1 amplification.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bortezomib and Pegylated Liposomal Doxorubicin in BRCA Wild-type Platinum-resistant Recurrent Ovarian Cancer Patients
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ovarian Neoplasm Epithelial
  • High Grade Serous Carcinoma
Intervention  ICMJE Drug: Pegylated liposomal doxorubicin plus Bortezomib
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
Study Arms  ICMJE Experimental: Pegylated liposomal doxorubicin plus Bortezomib combination
At BRCA wild-type platinum-resistant recurrent ovarian cancer patients, Pegylated liposomal doxorubicin and Bortezomib combination therapy for six cycles.
Intervention: Drug: Pegylated liposomal doxorubicin plus Bortezomib
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 25, 2018)
44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kidong Kim 82-31-787-7262 kidong.kim.md@gmail.com
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03509246
Other Study ID Numbers  ICMJE EBLIN
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Seoul National University Hospital
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP