Trial record 1 of 1 for:    NCT00690924
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Calcitriol in Preventing Lung Cancer in Smokers and Former Smokers at High Risk of Lung Cancer

This study is currently recruiting participants.
Verified December 2013 by Roswell Park Cancer Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00690924
First received: June 4, 2008
Last updated: December 26, 2013
Last verified: December 2013

June 4, 2008
December 26, 2013
July 2008
December 2015   (final data collection date for primary outcome measure)
Grade III-IV toxicities or any grade II toxicities lasting more than 2 weeks [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Grade III-IV toxicities or any grade II toxicities lasting more than 2 weeks [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00690924 on ClinicalTrials.gov Archive Site
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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

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.

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.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Lung Cancer
  • Precancerous Condition
  • Tobacco Use Disorder
  • Drug: calcitriol
    Oral
  • Other: laboratory biomarker analysis
    Correlative Study
  • Other: pharmacological study
    Correlative Study
Experimental: Calcitriol
Interventions:
  • Drug: calcitriol
  • Other: laboratory biomarker analysis
  • Other: pharmacological study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Not Provided
December 2015   (final data collection date for primary outcome measure)

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
Both
40 Years to 79 Years
No
Not Provided
United States
 
NCT00690924
CDR0000596506, P30CA016056, RPCI-I-90206
Yes
Roswell Park Cancer Institute
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Alex A. Adjei, MD, PhD Roswell Park Cancer Institute
Roswell Park Cancer Institute
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP