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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-15

Study Completion Date

2022-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dose-finding Study Comparing Efficacy and Safety of a PARP Inhibitor Against Doxil in BRCA+ve Advanced Ovarian Cancer

NCT00628251

Ovarian Neoplasms

COMPLETED PHASE2

Real-World Effectiveness of PLD in Platinum- Sensitive Recurrent Ovarian Cancer

NCT03562533

Ovarian Carcinoma

COMPLETED

An Observational Study of Combination of Pegylated Liposomal Doxorubicin and Trabectedin in Routine Practice in Patients With Recurrent Partial-platinum Sensitive Ovarian Cancer

NCT03446495

Ovarian Cancer

UNKNOWN

Study for Women With Platinum Resistant Ovarian Cancer Evaluating EC145 in Combination With Doxil® (PROCEED)

NCT01170650

Ovarian Cancer

TERMINATED PHASE3

Bortezomib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

NCT00023712

Primary Peritoneal Cavity Cancer Recurrent Ovarian Epithelial Cancer

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ovarian Neoplasm Epithelial High Grade Serous Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Pegylated liposomal doxorubicin plus Bortezomib

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No