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. (see Contacts and Locations)
Verified July 2014 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: July 2, 2014
Last verified: July 2014
  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 Phase
Lung Cancer
Precancerous Condition
Tobacco Use Disorder
Drug: calcitriol
Other: laboratory biomarker analysis
Other: pharmacological study
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: July 2008
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   40 Years to 79 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00690924

Locations
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263-0001
Contact: AskRPCI    877-275-7724    AskRPCI@RoswellPark.org   
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Alex A. Adjei, MD, PhD Roswell Park Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00690924     History of Changes
Other Study ID Numbers: CDR0000596506, P30CA016056, RPCI-I-90206
Study First Received: June 4, 2008
Last Updated: July 2, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Lung Neoplasms
Precancerous Conditions
Tobacco Use Disorder
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
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 18, 2014