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.
Checked against the public recordLast updated Jun 4, 2018 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Prevention
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- Roswell Park Cancer Institute
- Interventions being studied
- Drug: calcitriol; Other: laboratory biomarker analysis; Other: pharmacological study
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Roswell Park Cancer InstituteBuffalo, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 4, 2018. Always confirm current availability with the study team.