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

Primary Purpose

Lung Cancer, Precancerous Condition, Tobacco Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
calcitriol
laboratory biomarker analysis
pharmacological study
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Cancer focused on measuring lung cancer, tobacco use disorder, squamous lung dysplasia

Eligibility Criteria

40 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Calcitriol

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 4, 2008
Last Updated
May 1, 2018
Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00690924
Brief Title
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 17, 2008 (Actual)
Primary Completion Date
March 7, 2017 (Actual)
Study Completion Date
March 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Precancerous Condition, Tobacco Use Disorder
Keywords
lung cancer, tobacco use disorder, squamous lung dysplasia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calcitriol
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
calcitriol
Intervention Description
Oral
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative Study
Intervention Type
Other
Intervention Name(s)
pharmacological study
Intervention Description
Correlative Study
Primary Outcome Measure Information:
Title
Grade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 Weeks
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Reid, PhD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States

12. IPD Sharing Statement

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

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