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Completed

NCT Number: NCT05300828

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

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Ajou University School of Medicine

Suwon, South Korea

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Genexl PM

Drug

Every three weeks, after intravenous infusion of 260 mg/m2 for 3 hours, followed by carboplatin AUC 5 for 3 hours.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Samyang Biopharmaceuticals Corporation

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Mar 29, 2022
Registry last updated
Jun 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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