Calcitriol in Preventing Lung Cancer in Smokers and Former Smokers at High Risk of Lung Cancer

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