Clinical trial NCT00690924: Calcitriol in Preventing Lung Cancer in Smokers and Former Smokers at High Risk of Lung Cancer
Official title: A Pilot Study of Oral Calcitriol in Patients at High Risk for Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Precancerous Condition
Tobacco Use Disorder
Keywords: lung cancer
tobacco use disorder
squamous lung dysplasia
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-06-05
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

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 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

Primary outcomes:
measure: Grade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 Weeks
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Mary Reid, PhD
role: PRINCIPAL_INVESTIGATOR
References: