NCT00084409

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Iloprost may be effective in preventing lung cancer. PURPOSE: This randomized phase II trial is studying how well iloprost works in preventing lung cancer in patients who are at high risk for this disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for phase_2 lung-cancer

Timeline
Completed

Started Nov 2001

Longer than P75 for phase_2 lung-cancer

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2004

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

February 13, 2013

Completed
Last Updated

May 14, 2020

Status Verified

May 1, 2020

Enrollment Period

7.2 years

First QC Date

June 10, 2004

Results QC Date

November 26, 2012

Last Update Submit

May 12, 2020

Conditions

Lung CancerPrecancerous Condition

Keywords

non-small cell lung cancersquamous lung dysplasia

Outcome Measures

Primary Outcomes (1)

  • Change in Average (Follow-up - Baseline) From All Biopsies

    This outcome measure is created for each subject as follows: From all biopsies scored at the baseline bronchoscopy, the mean WHO score is calculated. From all biopsies scored at the follow-up bronchoscopy, the mean WHO score is calculated.Histology on bronchial biopsies pre-treatment and post-treatment will be compared. All biopsies will be graded according to the WHO classification for bronchial epithelium for this outcome, and all the following outcomes. WHO Classification Grade Normal 1.0 Reserve Cell Hyperplasia 2.0 Metaplasia 3.0 Mild Dysplasia 4.0 Moderate Dysplasia 5.0 Severe Dysplasia 6.0 Carcinoma in Situ 7.0 Carcinoma 8.0 The difference (follow-up mean - baseline mean) is used as the outcome measure for each subject.

    Nine years

Secondary Outcomes (10)

  • Change in Dysplasia Index (Follow-up - Baseline) Using All Biopsies

    9 Years

  • Change in Average (Follow-up - Baseline) Using Reference Sites

    9 Years

  • Change in Maximum (Follow-up - Baseline) Using Reference Sites

    9 Years

  • Change in Dysplasia Index (Follow-up - Baseline) Using Reference Sites

    9 Years

  • Change in Average (Follow-up - Baseline) Using Matched Sites

    9 Years

  • +5 more secondary outcomes

Other Outcomes (5)

  • To Determine if Iloprost Can Modulate K-67 Proliferation Index in Patients at High Risk to Develop Lung Cancer

    nine years

  • To Determine Whether Iloprost Affects Prostaglandin Metabolism by Examining 4 Markers, PGIS, COX-2, PPAR and PPAR.

    Nine years

  • To Determine the Toxicity Profile of Iloprost in Patients at High Risk to Develop Lung Cancer.

    Nine Years

  • +2 more other outcomes

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.

Drug: iloprost

Arm II

PLACEBO COMPARATOR

Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.

Other: placebo

Interventions

iloprostDRUG

Given orally

Arm I
placeboOTHER

Given orally

Arm II

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current or former smoker with ≥ 20 pack-year history of smoking with no tobacco use within the past 6 months
  • Mild atypia or worse on sputum cytology, or
  • Bronchial biopsy with mild or worse dysplasia within the past 12 months
  • Age 18 and over
  • SWOG (Southwest Oncology Group)0-2
  • Life expectancy at least 6 months
  • Granulocyte count \> 1,500/mm\^3
  • Platelet count \> 100,000/mm\^3
  • Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN)
  • Transaminases ≤ 2.5 times ULN
  • Bilirubin ≤ 2.0 mg/dL
  • Albumin ≥ 2.5 g/dL
  • Creatinine ≤ 1.5 mg/dL
  • Well-controlled atrial fibrillation OR rare (\< 2 minutes) premature ventricular contractions allowed
  • Negative pregnancy test
  • +2 more criteria

You may not qualify if:

  • Clinically apparent bleeding diathesis
  • Ventricular tachycardia
  • Multifocal premature ventricular contractions or supraventricular tachycardias with rapid ventricular response
  • Pneumonia or acute bronchitis within the past 2 weeks
  • Hypoxemia (\< 90% saturation with supplemental oxygen)
  • Pregnant or nursing
  • Malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • Serious medical condition that would preclude bronchoscopy or study participation
  • Clinically active coronary artery disease
  • Myocardial infarction within the past 6 weeks
  • Chest pain
  • Congestive heart failure
  • Cardiac dysrhythmia that is potentially life-threatening
  • Biologic therapy (Not specified)
  • More than 5 years since prior chemotherapy
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Veterans Affairs Medical Center - Denver

Denver, Colorado, 80220, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

UPMC Cancer Centers

Pittsburgh, Pennsylvania, 15232, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Related Publications (1)

  • Keith RL, Blatchford PJ, Kittelson J, Minna JD, Kelly K, Massion PP, Franklin WA, Mao J, Wilson DO, Merrick DT, Hirsch FR, Kennedy TC, Bunn PA Jr, Geraci MW, Miller YE. Oral iloprost improves endobronchial dysplasia in former smokers. Cancer Prev Res (Phila). 2011 Jun;4(6):793-802. doi: 10.1158/1940-6207.CAPR-11-0057.

    PMID: 21636546RESULT

Related Links

MeSH Terms

Conditions

Lung NeoplasmsPrecancerous ConditionsCarcinoma, Non-Small-Cell Lung

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Prostaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Results Point of Contact

Title
Robert Keith, M.D.
Organization
University of Colorado Denver
robert.keith@ucdenver.edu
303-399-8020

Study Officials

  • Robert Keith, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2004

First Posted

June 11, 2004

Study Start

November 1, 2001

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

May 14, 2020

Results First Posted

February 13, 2013

Record last verified: 2020-05

Locations

US(6)