Lung CancerNCT00690924

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

A study testing calcitriol, laboratory biomarker analysis and pharmacological study in people with Lung Cancer and Precancerous Condition, run by Roswell Park Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 40 to 79 years
Conditions the study is for: Lung Cancer, Precancerous Condition, Tobacco Use Disorder
What is being tested?: calcitriol, laboratory biomarker analysis and pharmacological study
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: 17 Jul 2008to 7 Mar 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Roswell Park Cancer Institute
Buffalo, New York, 14263-0001

Other trials in United States

About this study

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

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.

Read the 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
Being tested: calcitriol, laboratory biomarker analysis, pharmacological study
Keywords: lung cancer, tobacco use disorder, squamous lung dysplasia
Medical subject headings: Lung Neoplasms, Precancerous Conditions, Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

calcitriolDrug
Oral
laboratory biomarker analysisOther
Correlative Study
pharmacological studyOther
Correlative Study

Study groups in NCT00690924
Study group	Role	What they receive
Calcitriol	Experimental	Not described Receives: Drug: calcitriol; Other: laboratory biomarker analysis; Other: pharmacological study

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jul 20087 Mar 2018

First posted5 Jun 2008 (estimated)
Study start17 Jul 2008
Primary completion7 Mar 2017
Study completion7 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lung CancerStudies of the same condition, open and under way.
More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00690924
Sponsor's protocol ID: CDR0000596506
Other IDs: P30CA016056, I 90206
Status last verified: May 2018
First submitted: 4 Jun 2008
Last updated: 4 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer

All Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study of Oral Calcitriol in Patients at High Risk for Lung Cancer
ClinicalTrials.gov ID: NCT00690924
Acronym / sponsor ID: CDR0000596506
Conditions: Lung Cancer, Precancerous Condition, Tobacco Use Disorder
Keywords: lung cancer, tobacco use disorder, squamous lung dysplasia
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Roswell Park Cancer InstituteUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 17 Jul 2008 (actual)
Primary completion: 7 Mar 2017 (actual)
Study completion: 7 Mar 2018 (actual)
First posted: 5 Jun 2008 (estimated)
Results: Posted 11 Oct 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Calcitriol	Experimental	Drug: calcitriol, Other: laboratory biomarker analysis, Other: pharmacological study

Who may qualify

Ages: 40 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
calcitriolOral	Drug	Calcitriol
laboratory biomarker analysisCorrelative Study	Other	Calcitriol
pharmacological studyCorrelative Study	Other	Calcitriol

Primary outcome

Grade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 Weeks
Time frame: 3 months
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.

Results and safety

Results posted to the registry on 11 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Calcitriol	16	16

Primary outcome: Grade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 Weeks

Time frame: 3 months. Number. Unit: participants

Measure	Calcitriol n = 16
II	1
III	0
IV	0
V	0

Population analysed: All treated and eligible patients

Adverse events

Time frame: 4 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Calcitriol	0 of 16 (0%)	13 of 16 (81.3%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Lung Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mary Reid, PhD principal investigator

Roswell Park Cancer Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Grade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 Weeks (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00690924.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2018.