Itraconazole in Advanced Ovarian Cancer

Trial Title: Itraconazole in Advanced Ovarian Cancer

NCT ID: NCT05591560

Condition: Ovarian Carcinoma

Conditions: Official terms:
Itraconazole

Conditions: Keywords:
Itraconazole
Paclitaxel
Carboplatin
Chemotherapy
Epithelial
Ovarian
Carcinoma

Study type: Interventional

Study phase: N/A

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Participant)

Intervention:

Intervention type: Drug
Intervention name: Itraconazole capsule
Description: 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
Arm group label: Group II Itraconazole group

Intervention type: Drug
Intervention name: Placebo
Description: 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
Arm group label: Group I Placebo group

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.

Detailed description: 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). The staging of the disease will be done according to 8th edition of American Joint Committee on Cancer (AJCC), TNM staging. The patients will be recruited from Oncology Department, Tanta University Hospital. The patients will receive a combination of paclitaxel and carboplatin chemotherapy with or without itraconazole. Randomization will be carried out based on hospital admission days where the patients will be randomized into the following two groups to compare effect of adding Itraconazole to paclitaxel and carboplatin versus placebo to paclitaxel and carboplatin.

Criteria for eligibility:
Criteria:
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 .

Gender: Female

Gender based: Yes

Gender description: Measuring tumor response in epithelial ovarian carcinoma

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Tanta University, Faculty of Pharmacy

Address:
City: Tanta
Zip: 31111
Country: Egypt

Contact:
Last name: Ahmed ES Besheir, Master

Phone: 00201060943386
Email: ahmed.ezzat278@gmail.com

Start date: October 2022

Completion date: October 2024

Lead sponsor:
Agency: Tanta University
Agency class: Other

Source: Tanta University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05591560