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

Roswell Park Comprehensive Cancer Center

Status

Completed

Conditions

Tobacco Use Disorder

Precancerous Condition

Lung Cancer

Treatments

Other: pharmacological study

Drug: calcitriol

Other: laboratory biomarker analysis

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00690924

P30CA016056 (U.S. NIH Grant/Contract)

I 90206

CDR0000596506

Details and patient eligibility

About

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.

Full description

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.

Enrollment

16 patients

Sex

All

Ages

40 to 79 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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