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CompletedNot applicableNCT00690924
Official study title

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

Study 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.

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Key things to know

Main goalPrevention

This describes the study’s primary purpose.

What is being studiedcalcitriol and laboratory biomarker analysis

Plus 1 other study approaches.

Who it may be forLung Cancer · Precancerous Condition

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 4, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Roswell Park Cancer Institute

Study sponsor

01
Study overview

What this study is about

Purpose
Prevention
Study type
Interventional
Phase
Not applicable
Sponsor
Roswell Park Cancer Institute
Interventions being studied
Drug: calcitriol; Other: laboratory biomarker analysis; Other: pharmacological study
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Roswell Park Cancer InstituteBuffalo, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 4, 2018. Always confirm current availability with the study team.

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