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

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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 by National Cancer Institute (NCI), November 2008
Sponsors and Collaborators: Roswell Park Cancer Institute
National Cancer Institute (NCI)

Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00690924

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
Cancer-Related Problem/Condition
Lung Cancer
Precancerous/Nonmalignant Condition
Dietary Supplement: calcitriol
Other: laboratory biomarker analysis
Other: pharmacological study
Phase I




MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Calcitriol
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention
Official Title: A Pilot Study of Oral Calcitriol in Patients at High Risk for Lung Cancer


Further study details as provided by National Cancer Institute (NCI):


Primary Outcome Measures:
Grade III-IV toxicities or any grade II toxicities lasting more than 2 weeks [ Designated as safety issue: Yes ]


Estimated Enrollment: 40
Study Start Date: July 2008
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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
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
Creatinine clearance > 60 mL/min
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

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: Alex A. Adjei, MD, PhD 716-845-4101 alex.adjei@roswellpark.org

Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: Alex A. Adjei, MD, PhD Roswell Park Cancer Institute

More Information


Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers: CDR0000596506, RPCI-I-90206
Study First Received: June 4, 2008
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00690924 [history]
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
lung cancer
tobacco use disorder
squamous lung dysplasia



Study placed in the following topic categories:
Thoracic Neoplasms
Calcium, Dietary
Respiratory Tract Diseases
Precancerous Conditions
Lung Neoplasms
Lung Diseases
Tobacco Use Disorder
Calcitriol



Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms by Site
Neoplasms
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Calcium Channel Agonists
Bone Density Conservation Agents
Cardiovascular Agents
Pharmacologic Actions
Membrane Transport Modulators
Therapeutic Uses
Vitamins
Vasoconstrictor Agents
Micronutrients



ClinicalTrials.gov processed this record on February 10, 2009


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