Status:
COMPLETED
Calcitriol in Preventing Lung Cancer in Smokers and Former Smokers at High Risk of Lung Cancer
Lead Sponsor:
Roswell Park Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Precancerous Condition
Eligibility:
All Genders
40-79 years
Phase:
NA
Brief 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 preventin...
Detailed 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 r...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 17 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2018
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00690924
Start Date
July 17 2008
End Date
March 7 2018
Last Update
June 4 2018
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001