Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Genexl PM | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Genexol PM
- description
- Genexol PM/carboplatin combination treatment is performed as an adjuvant treatment after cytoreductive surgery for newly diagnosed ovarian cancer.
- interventionNames
- Drug: Genexl PM
Primary outcomes (1)
- measure
- Number of participants showing adverse events
- timeFrame
- From the time of treatment start date through 30 days following cessation of treatment
- description
- Number of any adverse event assessed based on CTCAE 4.0
Secondary outcomes (2)
- measure
- Neurotoxicity
- timeFrame
- From the time of treatment start date through 30 days following cessation of treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDLee 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. PMID 28324920
- BACKGROUNDLee 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. PMID 28028994