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

NCT00690924 | Completed Results DMC

• 3 other identifiers: CDR0000596506P30CA016056I 90206
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Precancerous Condition; Tobacco Use Disorder

Keywords

lung cancer; tobacco use disorder; squamous lung dysplasia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Calcitriol

EXPERIMENTAL

Drug: calcitriol; Other: laboratory biomarker analysis; Other: pharmacological study

Interventions

calcitriol DRUG

Oral

Calcitriol

laboratory biomarker analysis OTHER

Correlative Study

Calcitriol

pharmacological study OTHER

Correlative Study

Calcitriol

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Precancerous Conditions; Tobacco Use Disorder

Interventions

Calcitriol

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

Adrienne.Groman@RoswellPark.org

716-845-2300

Study Officials

• Mary Reid, PhD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2008
• First Posted: June 5, 2008
• Study Start: July 17, 2008
• Primary Completion: March 7, 2017
• Study Completion: March 7, 2018
• Last Updated: June 4, 2018
• Results First Posted: October 11, 2017

Record last verified: 2018-05

Locations

US (1)