Sulindac in Preventing Lung Cancer in Current or Former Smokers With Bronchial Dysplasia
Randomized, Phase IIb Trial of Sulindac in Smokers With Bronchial Dysplasia
6 other identifiers
interventional
61
2 countries
6
Brief Summary
This randomized phase II trial is studying sulindac to see how well it works compared to a placebo in preventing lung cancer in current or former smokers with bronchial dysplasia. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of sulindac may prevent lung cancer from forming in patients with bronchial dysplasia. It is not yet known whether sulindac is more effective than a placebo in preventing lung cancer in patients with bronchial dysplasia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2006
Typical duration for phase_2
6 active sites
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
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 24, 2006
CompletedFirst Posted
Study publicly available on registry
August 29, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
January 8, 2014
CompletedMay 23, 2014
October 1, 2011
3.8 years
August 24, 2006
November 14, 2013
May 7, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Response Determined by Change in Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples Before and After Treatment
Definition of response: complete response = regression of all dysplastic lesions (DL) to normal, hyperplasia or metaplasia with no new DL identified; partial response = regression of one or more, but not all of the DL with no new DL identified and no lesions worsening; progression = worsening at one or more sites by at least 2 histologic grades or appearance of any new DL that were not previously biopsied; stable disease = participants not classified as having a complete response, partial response, or progressive disease
Baseline and 6 months
Secondary Outcomes (1)
Percent Change in Number of Dysplastic Lesions (DL) as Measured by Mucosal Biopsy Samples Before and After the Intervention
Baseline and 6 months
Study Arms (2)
Arm I
EXPERIMENTALPatients receive oral sulindac twice daily for 6 months.
Arm II
PLACEBO COMPARATORPatients receive oral placebo twice daily for 6 months.
Interventions
Eligibility Criteria
You may qualify if:
- Current or former smoker who has smoked at least 30 pack years AND meets 1 of the following criteria:
- No prior lung cancer
- Prior stage I non-small cell lung cancer(NSCLC) that was completely resected ≥ 1 year ago OR for which patient completed adjuvant chemotherapy ≥ 1 year ago
- Tissue blocks, blood, and sputum samples available for research purposes
- No carcinoma in situ
- ECOG performance status 0-1
- Hemoglobin ≥ 12.0 g/dL (women) or hemoglobin ≥ 13.5 g/dL (men)
- WBC ≥ 3,000/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT ≤ 1.5 times ULN
- Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥30 mL/min
- Room air oxygen saturation ≥ 90%
- Not pregnant or nursing
- +45 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
British Columbia
Vancouver, British Columbia, V5Z 1L3, Canada
Related Publications (1)
Limburg PJ, Mandrekar SJ, Aubry MC, Ziegler KL, Zhang J, Yi JE, Henry M, Tazelaar HD, Lam S, McWilliams A, Midthun DE, Edell ES, Rickman OB, Mazzone P, Tockman M, Beamis JF, Lamb C, Simoff M, Loprinzi C, Szabo E, Jett J; Cancer Prevention Network. Randomized phase II trial of sulindac for lung cancer chemoprevention. Lung Cancer. 2013 Mar;79(3):254-61. doi: 10.1016/j.lungcan.2012.11.011. Epub 2012 Dec 20.
PMID: 23261228DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- James R. Jett, M.D.
- Organization
- National Jewish Health
Study Officials
- PRINCIPAL INVESTIGATOR
James Jett
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2006
First Posted
August 29, 2006
Study Start
August 1, 2006
Primary Completion
May 1, 2010
Study Completion
December 1, 2010
Last Updated
May 23, 2014
Results First Posted
January 8, 2014
Record last verified: 2011-10