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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14263-0001
- Roswell Park Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Calcitriol
|
Correlative Study
Oral
Correlative Study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Tobacco Use Disorder
- Precancerous Conditions
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Micronutrients
- Membrane Transport Modulators
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vasoconstrictor Agents
- Calcium Channel Agonists
- Calcitriol
Other Study ID Numbers
- CDR0000596506
- P30CA016056 (U.S. NIH Grant/Contract)
- I 90206
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