Clinical trial · Interventional
Itraconazole in Advanced Ovarian Cancer
The Possible Effect of Itraconazole as add-on Therapy to Paclitaxel and Carboplatin on the Treatment Outcome in Patients With Advanced Ovarian Cancer
- 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)
This is a randomized, placebo controlled; parallel study that will be conducted on 66 female patients with advanced epithelial ovarian carcinoma (stage III and stage IV) to compare effect of adding Itraconazole to paclitaxel and carboplatin versus placebo to paclitaxel and carboplatin as regard overall response rate (ORR) and Disease control rate (DCR) and Quality of life (QOL) and the change in the serum concentrations of the biological markers.
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 Carcinoma | Ovarian Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Itraconazole capsule | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Group I Placebo group
- description
- Group I (Placebo group; n=33) which will be treated with chemotherapy which includes paclitaxel 60 mg/m2 IV over 1 hour followed by carboplatin area under the curve 2 (AUC 2) IV over 30 minutes Day 1, 8, and 15 which will be repeated every 21 days for 6 cycles 12 plus 4 placebo capsules for 5 days (two days before chemotherapy, the day of chemotherapy after receiving it, and two days after chemotherapy).
- interventionNames
- Drug: Placebo
- type
- ACTIVE_COMPARATOR
- label
- Group II Itraconazole group
- description
- Group II: (Itraconazole group; n=33) which will be treated with chemotherapy which includes paclitaxel 60 mg/m2 IV over 1 hour followed by carboplatin AUC 2 IV over 30 minutes Day 1, 8, and 15 repeated every 21 days for 6 cycles 12 plus oral itraconazole 400 mg (4 capsules, each of 100 mg) for 5 days (two days before chemotherapy, the day of chemotherapy after receiving it, and two days after chemotherapy).
- interventionNames
- Drug: Itraconazole capsule
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients Age \>18 years old \< 65 years old. * Patients with histopathological and radiological based diagnosis of III, IV epithelial ovarian carcinoma according to 8th edition AJCC, primary tumor, regional nodes, metastasis (TNM) staging system.11 * Patients with Eastern Cooperative Oncology Group Performance Status of 0 or 1. 13 * Patients able to swallow and retain oral medications (without crushing, dissolving, or chewing tablets). * Patients with adequate hematologic and organ function within 14 days before the first Cycle which can be defined by the following: * Neutrophils (absolute neutrophil count (ANC) \>1.5 X 10\^9/L). * Hemoglobin \>9 g/dl. * Platelet count \>100,000/L. * Serum albumin \>3 g/dl. * Total bilirubin 1.5 ≤ of the upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine transaminase ( ALT) ≤ 2 of the upper limit of normal (ULN). * Serum creatinine ≤ 1.5 of the upper limit of normal (ULN) or estimated creatinine clearance \>50 mL/min based on Cockcroft-Gault glomerular filtration rate estimation. Exclusion Criteria: * Presence of 2nd primary malignancy * History of allergic reactions attributed to paclitaxel, carboplatin, and itraconazole or to compounds of similar chemical or biologic composition to itraconazole. * Concurrent use of medications significantly affecting metabolism of itraconazole (certain anti-convulsants). * Patients with hyperthyroidism (which would increase metabolism of itraconazole). * Patients with grade ≥ 2 neuropathy. * Patients with Uncontrolled, concurrent medical illness. * Patients with active hepatitis or symptomatic liver disease. * History of or current evidence of uncontrolled cardiac ventricular dysfunction (congestive heart failure) or patients with class III and class IV heart failure according to New York Heart Association (NYHA). * Pregnant or lactating female .
References
Publications (4)
- BACKGROUNDGoenka L, Dubashi B, Selvarajan S, Ganesan P. Use of "Repurposed" Drugs in the Treatment of Epithelial Ovarian Cancer: A Systematic Review. Am J Clin Oncol. 2022 Apr 1;45(4):168-174. doi: 10.1097/COC.0000000000000900. PMID 35320817
- BACKGROUNDNunes M, Henriques Abreu M, Bartosch C, Ricardo S. Recycling the Purpose of Old Drugs to Treat Ovarian Cancer. Int J Mol Sci. 2020 Oct 20;21(20):7768. doi: 10.3390/ijms21207768. PMID 33092251
- BACKGROUNDMohamed AW, Elbassiouny M, Elkhodary DA, Shawki MA, Saad AS. The effect of itraconazole on the clinical outcomes of patients with advanced non-small cell lung cancer receiving platinum-based chemotherapy: a randomized controlled study. Med Oncol. 2021 Feb 9;38(3):23. doi: 10.1007/s12032-021-01475-0. PMID 33559053
- BACKGROUNDLi CL, Fang ZX, Wu Z, Hou YY, Wu HT, Liu J. Repurposed itraconazole for use in the treatment of malignancies as a promising therapeutic strategy. Biomed Pharmacother. 2022 Oct;154:113616. doi: 10.1016/j.biopha.2022.113616. Epub 2022 Aug 30. PMID 36055112