Safety of Genexol PM and Carboplatin as First-line Therapy in Ovarian Cancer

June 23, 2023 updated by: Hee Seung Kim, Seoul National University Hospital

An Observational Study to Evaluate the Safety of the Combination Therapy of Genexol PM and Carboplatin as First-line Therapy for Ovarian Cancer Patients

To evaluate the safety profile of Genexol PM combination with carboplatin for patients with newly diagnosed ovarian cancer. We hypothesized Genexol PM can be safely administered to newly diagnosed ovarian cancer patients compared to conventional paclitaxel/carboplatin combination therapy. Therefore, we will compare the prospective cohort with a historical comparison with patients administered paclitaxel/carboplatin and paclitaxel/carboplatin/bevacizumab combination therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Suwon, Korea, Republic of
        • Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Ajou University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients at tertiary hospital

Description

Inclusion Criteria:

  • Age over 18
  • Patients consented to participate
  • Pathologically diagnosed ovarian cancer FIGO stage IC-IVB
  • ECOG 0-2
  • Patients with an expected survival of 3 months or more

Exclusion Criteria:

  • History of paclitaxel or carboplatin hypersensitivity
  • Inadequate bone marrow function (Neutrophil<1500/mm3, Platelet <100,000/mm3)
  • Pregnancy or breast-feeding state
  • Metachronous or synchronous malignancy
  • Galactose intolerance, Lapp Lactase deficiency, or glucose-galactose malabsorption patients with genetic problems
  • Other patients who were judged difficult to be included in this investigation by the investigator in charge

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Genexol PM
Genexol PM/carboplatin combination treatment is performed as an adjuvant treatment after cytoreductive surgery for newly diagnosed ovarian cancer.
Drug: Genexl PM
Every three weeks, after intravenous infusion of 260 mg/m2 for 3 hours, followed by carboplatin AUC 5 for 3 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants showing adverse events
Time Frame: From the time of treatment start date through 30 days following cessation of treatment
Number of any adverse event assessed based on CTCAE 4.0
From the time of treatment start date through 30 days following cessation of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurotoxicity
Time Frame: From the time of treatment start date through 30 days following cessation of treatment
Number of participants showing grade 3/4 neurotoxicity assessed based on CTCAE 4.0
From the time of treatment start date through 30 days following cessation of treatment
other toxicity
Time Frame: From the time of treatment start date through 30 days following cessation of treatment
Number of participants showing grade 3/4 any toxicity assessed based on CTCAE 4.0
From the time of treatment start date through 30 days following cessation of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Samyang Biopharmaceuticals Corporation

Investigators

  • Principal Investigator: Hee Seung Kim, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2015

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

March 19, 2022

First Submitted That Met QC Criteria

March 19, 2022

First Posted (Actual)

March 29, 2022

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 23, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GENEXOL PM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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