Itraconazole in Advanced Ovarian Cancer

NCT05591560 | Unknown

• 1 other identifier: 35929/10/22
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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

Ovarian Carcinoma

Keywords

Itraconazole; Paclitaxel; Carboplatin; Chemotherapy; Epithelial; Ovarian; Carcinoma

Outcome Measures

Primary Outcomes (1)

• The change between 2 groups in overall response rate and disease control rate

  The change between 2 groups in overall response rate and disease control rate using the Response Evaluation Criteria in Solid Tumors (RECIST), version. 1.1.

  1 week after the end of chemotherapy cycle 3 and 6 (each cycle is 21 days) and every 2 to 4 months after the end of 6 chemotherapy cycles (each cycle is 21 days) for 1 year

Secondary Outcomes (1)

• The change in the serum concentrations of the biological markers (CA-125, VEGFR-2, P-glycoprotein).

  1 week after the end of chemotherapy cycle 3 and 6 (each cycle is 21 days) and every 2 to 4 months after the end of 6 chemotherapy cycles (each cycle is 21 days) for 1 year

Study Arms (2)

Group I Placebo group

PLACEBO COMPARATOR

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).

Drug: Placebo

Group II Itraconazole group

ACTIVE COMPARATOR

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).

Drug: Itraconazole capsule

Interventions

Itraconazole capsule DRUG

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) Day 1, 8, and 15 repeated every 21 days for 6 cycles for group II

Group II Itraconazole group

Placebo DRUG

4 placebo capsules for 5 days (two days before chemotherapy, the day of chemotherapy after receiving it, and two days after chemotherapy) Day 1, 8, and 15 repeated every 21 days for 6 cycles for group I

Group I Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Measuring tumor response in epithelial ovarian carcinoma
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University, Faculty of Pharmacy

Tanta, 31111, Egypt

Location

Related Publications (4)

• Goenka 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 BACKGROUND

• Nunes 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 BACKGROUND

• Mohamed 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 BACKGROUND

• Li 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 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Tarek M Mostafa, Professor

  Tanta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed ES Besheir, Master

CONTACT

00201060943386; ahmed.ezzat278@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacist

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 24, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: October 24, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)