Itraconazole in Non Small Cell Lung Cancer
Lung Cancer
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring Non small cell lung cancer, itraconazole, mtor inhibition, antiangiogensis, antifungal, anticancer, platinum based chemotherapy
Eligibility Criteria
Inclusion Criteria:
- Stage IV NSCLC patients who have not received chemotherapy for metastatic disease management yet or inoperable locally recurrent Stage III NSCLC after concurrent chemoradiotherapy.
- ECOG 0-2.
- Age >18 years.
- Adequate bone marrow reserve (white blood cells [WBC] ≥ 3.5 × 109 /L, neutrophils ≥ 1.5 × 109 /L, platelets ≥ 100 × 109 /L, and hemoglobin ≥ 9.0 gm/dL).
Exclusion Criteria:
- Inadequate liver function (bilirubin > 1.5 times upper normal limit [ULN] and alanine transaminase [ALT] or aspartate transaminase [AST] > 3.0 ULN or up to 5.0 UNL in the presence of hepatic metastases).
- Inadequate renal function (creatinine > 1.25 times ULN, creatinine clearance < 50mL/min).
- Serious comorbid systemic disorder incompatible with the study.
- Presence of other primary malignancy.
- Patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF.
- Patients with hypersensitivity to Itraconazole.
- Patients receiving any Cytochrome P450 (CYP 3A4) inhibitor as clarithromycin, diltiazem, verapamil, quinidine ….etc.
- Pregnant female patients.
Sites / Locations
- oncology department Ain shams universityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Itraconazole Arm
Control Arm
Patients will receive intravenous doses of cisplatin 80 mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8 every 3 weeks for a maximum of 6 cycles + itraconazole 200 mg oral tablet daily, on a 21-day cycle. Alternatively, Carboplatin may be used instead of Cisplatin, Carbplatin AUC 5 DAY 1 only Dose = AUC x (GFR + 25) IV in 250 mL Normal Saline over 30 minutes
Patients will receive intravenous doses of cisplatin 80 mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8 every 3 weeks for a maximum of 6 cycles. Alternatively, Carboplatin may be used instead of Cisplatin, Carbplatin AUC 5 DAY 1 only Dose = AUC x (GFR + 25) IV in 250 mL Normal Saline over 30 minutes