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

Ovarian Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05300828
• Other study ID #: GENEXOL PM
• Status: Completed
• Start date: October 19, 2015
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 31, 2022
• Est. primary completion date: April 30, 2022
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Ajou University School of Medicine	Suwon

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Samyang Biopharmaceuticals Corporation

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Lee SW, Kim YM, Cho CH, Kim YT, Kim SM, Hur SY, Kim JH, Kim BG, Kim SC, Ryu HS, Kang SB. An Open-Label, Randomized, Parallel, Phase II Trial to Evaluate the Efficacy and Safety of a Cremophor-Free Polymeric Micelle Formulation of Paclitaxel as First-Line Treatment for Ovarian Cancer: A Korean Gynecologic Oncology Group Study (KGOG-3021). Cancer Res Treat. 2018 Jan;50(1):195-203. doi: 10.4143/crt.2016.376. Epub 2017 Mar 21. — View Citation

Lee SW, Kim YM, Kim YT, Kang SB. An open-label, multicenter, phase I trial of a cremophor-free, polymeric micelle formulation of paclitaxel combined with carboplatin as a first-line treatment for advanced ovarian cancer: a Korean Gynecologic Oncology Group study (KGOG-3016). J Gynecol Oncol. 2017 May;28(3):e26. doi: 10.3802/jgo.2017.28.e26. Epub 2016 Dec 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants showing adverse events	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	Neurotoxicity	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
Secondary	other toxicity	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