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

A Pilot Study of Oral Calcitriol in Patients at High Risk for Lung Cancer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00690924
Enrollment
16
Registered
2008-06-05
Start date
2008-07-17
Completion date
2018-03-07
Last updated
2018-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Precancerous Condition, Tobacco Use Disorder

Keywords

lung cancer, tobacco use disorder, squamous lung dysplasia

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 preventing lung cancer in current smokers and former smokers at high risk of lung cancer.

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 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.

Interventions

DRUGcalcitriol

Oral

OTHERlaboratory biomarker analysis

Correlative Study

OTHERpharmacological study

Correlative Study

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Roswell Park Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 79 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Grade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 Weeks3 monthsNumber of participants with Adverse Events, Grade II lasting more than two weeks or Grade III or higher, graded according to CTEP Version 4 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.

Countries

United States

Participant flow

Participants by arm

ArmCount
Calcitriol
calcitriol: Oral laboratory biomarker analysis: Correlative Study pharmacological study: Correlative Study
16
Total16

Baseline characteristics

CharacteristicCalcitriol
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
4 Participants
Age, Categorical
Between 18 and 65 years
12 Participants
Age, Continuous60.1 years
STANDARD_DEVIATION 8.6
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
16 Participants
Sex: Female, Male
Female
6 Participants
Sex: Female, Male
Male
10 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 16
other
Total, other adverse events
13 / 16
serious
Total, serious adverse events
0 / 16

Outcome results

Primary

Grade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 Weeks

Number of participants with Adverse Events, Grade II lasting more than two weeks or Grade III or higher, graded according to CTEP Version 4 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.

Time frame: 3 months

Population: All treated and eligible patients

ArmMeasureGroupValue (NUMBER)
CalcitriolGrade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 WeeksII1 participants
CalcitriolGrade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 WeeksIII0 participants
CalcitriolGrade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 WeeksIV0 participants
CalcitriolGrade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 WeeksV0 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026