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

Seoul National University

Status: Completed

Conditions: Ovarian Cancer

Treatments: Drug: Genexl PM

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05300828

GENEXOL PM

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

600 participants in 1 patient group

Genexol PM

Description:

Genexol PM/carboplatin combination treatment is performed as an adjuvant treatment after cytoreductive surgery for newly diagnosed ovarian cancer.

Treatment:

Drug: Genexl PM