Calcitriol in Preventing Lung Cancer in High-Risk Patients

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Basic Trial Information

PhaseTypeAgeTrial IDs
No phase specifiedBiomarker/Laboratory analysis, Prevention40 to 79I 90206
NCI-2013-00841, CDR0000596506, RPCI # I 90206, I 90205, NCT00690924

Trial Description



This pilot clinical trial studies the side effects of calcitriol in preventing lung cancer in high risk patients. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of calcitriol may keep cancer from forming in patients with high risk for lung cancer.

Further Study Information


I. To establish the safety of 45 mcg dose of oral calcitriol every other week (QOW) in non-cancer patients.


Patients receive calcitriol orally (PO) QOW on days 1 and 15. Treatment repeats every 28 days for up to 3 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days.

Eligibility Criteria

Inclusion Criteria:

Must have pathologically confirmed squamous metaplasia or squamous dysplasia documented by autofluorescence bronchoscopy within the preceding 60 months

Must be a former or current smoker

Total granulocyte count of > 1.5 x 10^9/L

Platelet count of > 100 x 10^9/L

Participants must have adequate renal function with a calculated creatinine clearance of > 60 ml/min from a serum specimen collection at baseline using the Cockcroft-Gault formula

Participants must have a 24-hour calcium concentration that is =< 300 mg/24 hours as measured by 24-hour urine collection at baseline

Total bilirubin less than the upper limit of normal

Transaminases =< 2.5 x institutional upper limit of normal (IULN)

Alkaline phosphatase =< 2.5 x IULN

Albumin of >= 2.5 g/dl

Participants must have an ionized serum calcium within normal limits

Must meet Eastern Cooperative Oncology Group (ECOG) performance status criteria of 0-1 (0 = fully active, must be able to carry out all pre-disease activities without restriction; 1 = restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature)

Must be willing to attend all scheduled study visits, complete all study questionnaires, and allow biological specimen collection including a bronchoscopy within 3-4 months after enrollment into the study

Women of child-bearing potential (i.e. women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptives or double barrier device) and must have a negative serum or urine pregnancy test within 1 week prior to beginning treatment on this trial; sexually active men must also use acceptable contraceptive methods; pregnant or nursing patients are excluded from participating in this trial; contraceptive use needs to be continued at least 1 month after the trial has ended

Must be able and willing to sign an informed consent approved by the Institutional Review Board (IRB)

Exclusion Criteria:

Subjects with life-threatening medical conditions that would preclude bronchoscopy, including: acute cardiac failure, which is unstable despite medication use; uncontrolled hypertension; uncontrolled diabetes mellitus; or unstable coronary artery disease

Patients with severe metabolic disorders that would preclude administration of calcitriol

Evidence of current disease with lung cancer or head and neck cancer

Patients may have a prior history of lung cancer or head and neck cancer treated with curative intent, provided that there has been no evidence of disease (NED) for > 1 year; the qualifying autofluorescence (AF) bronchoscopy must be negative for malignancy

Patients with a history of any other malignancy within 3 years except non-melanoma skin and cervical carcinoma in situ (CIS)

Patients with a history of renal lithiasis within the last 5 years or patients with evidence of kidney stones on entry evaluation

Patients with impaired renal function creatinine clearance (CRCL) =< 60 mL/min

Patients with hypercalcemia (using ionized calcium)

Subjects taking calcium supplements; if subjects are willing to discontinue these supplements, there must be a 2-month wash out period before enrollment

If patients are routinely taking a multivitamin supplement, they will be asked to continue the supplement as long as the amount of vitamin D in the supplement is not in excess of the RDA (recommended daily allowance); if they are not taking a multivitamin supplement, they will be asked to not start supplementation while on study

Subjects with a known hypersensitivity to calcitriol

Subjects taking thiazides (which can decrease urinary excretion of calcium)

Patients taking phenobarbital, digitalis, thiazides or ketoconazole

Patients taking digoxin or patients who are susceptible to calcium-related dysrhythmias

Patients taking bile acid binding drugs (such as cholestyramine and colestipol)

Patients taking danazol

Patients taking aluminum-based antacids

Oral ketoconazole or other azole antifungals

Women who are pregnant or lactating are excluded from the study

No known allergies to tree nuts (i.e. almonds)

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Roswell Park Cancer Institute

  • National Cancer Institute
Alex A. Adjei, Principal Investigator

Trial Sites


New York

Roswell Park Cancer Institute

Alex A. Adjei
Ph: 716-845-4101

Alex A. Adjei
Principal Investigator

Link to the current record.
NLM Identifer NCT00690924

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