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

Seoul National University Hospital600 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

600

Conditions

Ovarian Cancer

Interventions

Genexl PMDRUG

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Suwon, South Korea

Outcomes

Primary Outcomes

Number of participants showing adverse events

Number of any adverse event assessed based on CTCAE 4.0

Time frame: From the time of treatment start date through 30 days following cessation of treatment

Secondary Outcomes

Neurotoxicity

Number of participants showing grade 3/4 neurotoxicity assessed based on CTCAE 4.0

Time frame: From the time of treatment start date through 30 days following cessation of treatment

other toxicity

Number of participants showing grade 3/4 any toxicity assessed based on CTCAE 4.0

Time frame: From the time of treatment start date through 30 days following cessation of treatment

Data from ClinicalTrials.gov

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