A Randomized Phase II Study of SUBATM-itraconazole with Cisplatin/Gemcitabine in Patients with Previously Untreated Metastatic Squamous Non-Small Cell Lung Cancer
This research is being done to find out whether SUBATM-itraconazole, an investigational drug based on a medication normally given for fungal infection, can slow the growth of lung cancer, when combined with cisplatin and gemcitabine (two standard cancer drugs for lung cancer).
Confirmed stage IV squamous cell lung cancer with no prior systemic chemotherapy. Mixed non-small cell histologies are eligible if squamous is predominant. Prior adjuvant chemotherapy for early-stage lung cancer is allowed if greater than 6 months have elapsed from therapy. Radiotherapy for locally advanced NSCLC is allowed if recurrence is outside of therapy port and had been completed greater than 2 weeks prior to enrollment. Normal blood and organ functions. Brain metastases are allowed if treated and patient has stable neurological status for at least 2 weeks after treatment. Itraconazole is a strong CYP3A4 inhibitor and may increase plasma concentrations of drugs metabolized by this pathway. Co-administration of cisapride, midazolam, pimozide, quinidine, lovastatin, simvastatin, triazolam, dofetilide, or levacetylmethadol (levomethadyl) with SUBATM-itraconazole or itraconazole is contraindicated.
This is a randomized trial. All patients (ARM A and ARM B) will receive Cisplatin 75 mg/m2 IV infusion over 60 min on Day 1 only; Gemcitabine 1000 mg/m2 IV infusion over 30 minutes on Days 1 and 8 of 21 day cycles. If a patient experiences a response, remains stable and has acceptable toxicity, a maximum of 6 cycles is allowed. ARM A only will receive oral drug SUBATM-itraconazole 200 mg twice daily with the Cisplatin/Gemcitabine combination. Drug is to be taken 30 minutes prior to meals, on a continuous 21 day cycle. ARM A patients may continue SUBATM-itraconazole up to 1 year as maintenance therapy after completion of chemotherapy, if tolerated and there is no progression of disease.
12/10/2013 04:02 AM