calcitriol in preventing lung cancer in smokers and former smokers at high risk of lung cancer

Conditions: Lung Cancer; Precancerous Condition; Tobacco Use Disorder

Summary: rationale: calcitriol may prevent lung cancer in patients with metaplasia or dysplasia of the lungs. purpose: this clinical trial is studying the side effects and best dose of calcitriol in preventing lung cancer in current smokers and former smokers at high risk of lung cancer.

objectives: primary * to establish the safety of calcitriol in patients at high risk of lung cancer. * to determine the dose-limiting toxicities of calcitriol in these patients. outline: patients receive oral calcitriol on day 1. courses repeat every 2 weeks for 3 months in absence of unacceptable toxicity. patients undergo blood collection periodically for pharmacokinetic and molecular analysis. after completion of study therapy, patients are followed periodically.

Eligibility criteria:
disease characteristics: * pathologically confirmed squamous metaplasia or squamous dysplasia of the lungs by autofluorescence bronchoscopy within the past 5 years * must be a current or former smoker * no evidence of concurrent disease with lung cancer or head and neck cancer * history of treated lung cancer or head and neck cancer treated with curative intent allowed, provided that there has been no evidence of disease for \> 1 year patient characteristics: * ecog performance status 0-1 * total granulocyte count \> 1,500 x 10\^9cells/l * platelet count \> 100,000 x 10\^9cells/l * calculated creatinine clearance \> 60 ml/min (using the cockcroft-gault formula) * calcium concentration 50-300 mg/24 hours * total bilirubin 0.2-1.3 mg% * alt/ast ≤ 2.5 times upper limit of normal (uln) * alkaline phosphatase ≤ 2.5 times uln * albumin ≥ 2.5 g/dl * ionized serum calcium normal (1.19-1.29 mmol/l) * corrected serum calcium ≤ 10.2 mg/dl * willing to attend all scheduled study visits, complete all study questionnaires, and allow biological specimen collection, including a bronchoscopy * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for at least 1 month after completion of study therapy * no life-threatening medical conditions that would preclude bronchoscopy, including but not limited to, any of the following: * acute cardiac failure * uncontrolled hypertension * uncontrolled diabetes mellitus * unstable coronary artery disease * no severe metabolic disorders that would preclude calcitriol administration * no history of any other malignancy within 3 years except for nonmelanoma skin cancer or cervical carcinoma in situ * no history or evidence of kidney stones * no patients who are susceptible to calcium-related dysrhythmias * no known hypersensitivity to calcitriol * no known allergies to tree nuts (i.e., almonds) prior concurrent therapy: * at least 2 months since prior and no concurrent calcium supplements * concurrent multivitamin supplement allowed provided the amount of vitamin d in the supplement is not in excess of the recommended daily dose * no concurrent thiazides, phenobarbital, or digitalis * no concurrent digoxin * no concurrent bile acid binding drugs (i.e., cholestyramine, colestipol) * no concurrent danazol or aluminum-based antacids * no concurrent ketoconazole or other azole antifungals

Keywords: lung cancer tobacco use disorder squamous lung dysplasia