Clinical Trials /

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

NCT03509246

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.

Related Conditions:
  • Fallopian Tube Carcinoma
  • Ovarian Carcinoma
  • Peritoneal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

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

DrugSynonymsArms
Pegylated liposomal doxorubicin plus BortezomibPegylated 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. 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

NameTypeDescriptionInterventions
Pegylated liposomal doxorubicin plus Bortezomib combinationExperimentalAt BRCA wild-type platinum-resistant recurrent ovarian cancer patients, Pegylated liposomal doxorubicin and Bortezomib combination theraphy for 6 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
             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 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, frequency of drug adverse 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:Not yet recruiting
Lead Sponsor:Seoul National University Hospital

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