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

NCT ID: NCT00690924

Last Updated: 2018-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-17
• Study Completion Date: 2018-03-07

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.

Conditions

Lung Cancer; Precancerous Condition; Tobacco Use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Calcitriol

Group Type: EXPERIMENTAL

calcitriol

Intervention Type: DRUG

Oral

laboratory biomarker analysis

Intervention Type: OTHER

Correlative Study

pharmacological study

Intervention Type: OTHER

Correlative Study

Interventions

calcitriol

Oral

Intervention Type: DRUG

laboratory biomarker analysis

Correlative Study

Intervention Type: OTHER

pharmacological study

Correlative Study

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary Reid, PhD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

P30CA016056

Identifier Type: NIH

Identifier Source: secondary_id

View Link

I 90206

Identifier Type: -

Identifier Source: secondary_id

CDR0000596506

Identifier Type: -

Identifier Source: org_study_id

NCT01896804

Identifier Type: -

Identifier Source: nct_alias