Clinical trial · Interventional
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
NCT00690924CI-TRIAL-00033162completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Precancerous Condition | — | UNRESOLVED | — |
| Tobacco Use Disorder | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| calcitriol | Drug | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Calcitriol
- interventionNames
- Drug: calcitriol
- Other: laboratory biomarker analysis
- Other: pharmacological study
Primary outcomes (1)
- measure
- Grade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 Weeks
- timeFrame
- 3 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.