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

Lung Cancer Clinical Trial

Official title:

A Pilot Study of Oral Calcitriol in Patients at High Risk for Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00690924
• Other study ID #: CDR0000596506
• Secondary ID: P30CA016056I 902
• Status: Completed
• Phase: N/A
• Start date: July 17, 2008
• Est. completion date: March 7, 2018

Study information

• Verified date: May 2018
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT01896804

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 7, 2018
• Est. primary completion date: March 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Precancerous Condition
• Precancerous Conditions
• Tobacco Use Disorder

Intervention

Drug:
• calcitriol
Oral

Other:
• laboratory biomarker analysis
Correlative Study
• pharmacological study
Correlative Study

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 Weeks	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