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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05300828

Enrollment

600

Registered

2022-03-29

Start date

2015-10-19

Completion date

2022-12-31

Last updated

2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Brief summary

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.

Interventions

DRUGGenexl PM

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Number of participants showing adverse events	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

Measure	Time frame	Description
Neurotoxicity	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
other toxicity	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026