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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 ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00690924
First Posted: June 5, 2008
Last Update Posted: October 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute
  Purpose

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.


Condition Intervention
Lung Cancer Precancerous Condition Tobacco Use Disorder Drug: calcitriol Other: laboratory biomarker analysis Other: pharmacological study

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pilot Study of Oral Calcitriol in Patients at High Risk for Lung Cancer

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Grade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 Weeks [ Time Frame: 3 months ]

    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.



Enrollment: 16
Actual Study Start Date: July 17, 2008
Estimated Study Completion Date: March 7, 2018
Primary Completion Date: March 7, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Calcitriol Drug: calcitriol
Oral
Other: laboratory biomarker analysis
Correlative Study
Other: pharmacological study
Correlative Study

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00690924


Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: Mary Reid, PhD Roswell Park Cancer Institute
  Study Documents (Full-Text)

Documents provided by Roswell Park Cancer Institute:
  More Information

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00690924     History of Changes
Obsolete Identifiers: NCT01896804
Other Study ID Numbers: CDR0000596506
P30CA016056 ( U.S. NIH Grant/Contract )
I 90206
First Submitted: June 4, 2008
First Posted: June 5, 2008
Results First Submitted: July 13, 2017
Results First Posted: October 11, 2017
Last Update Posted: October 30, 2017
Last Verified: October 2017

Keywords provided by Roswell Park Cancer Institute:
lung cancer
tobacco use disorder
squamous lung dysplasia

Additional relevant MeSH terms:
Lung Neoplasms
Tobacco Use Disorder
Precancerous Conditions
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Calcitriol
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents