Official Title: “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 Type: Interventional

Study Design: Prevention

Study Primary Completion Date: December 2010

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.

Intervention(s) in this Clinical Trial

• Dietary Supplement: calcitriol
• Other: laboratory biomarker analysis
• Other: pharmacological study

Primary Measures

• Grade III-IV toxicities or any grade II toxicities lasting more than 2 weeks
  • Safety Issue?: Yes

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
• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 79 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Roswell Park Cancer Institute

Overall Clinical Trial Officials and Contacts

Alex A. Adjei, MD, PhD Principal Investigator Roswell Park Cancer Institute  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00690924

Study ID Number: CDR0000596506

ClinicalTrials.gov Identifier: NCT00690924

Health Authority: Unspecified

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