Calcitriol in Preventing Lung Cancer in Smokers and Former Smokers at High Risk of Lung Cancer (NCT00690924) | Clinical Trial Compass
CompletedNot Applicable
Calcitriol in Preventing Lung Cancer in Smokers and Former Smokers at High Risk of Lung Cancer
United States16 participantsStarted 2008-07-17
Plain-language 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 preventing lung cancer in current smokers and former smokers at high risk of lung cancer.
Who can participate
Age range40 Years – 79 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Grade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 Weeks