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.
- To establish the safety of calcitriol in patients at high risk of lung cancer.
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.
Minimum age: 40 Years.
Maximum age: 79 Years.
Gender(s): Both.
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