Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084409
Status:
COMPLETED
Last Update Posted:
2020-05-14
First Post:
2004-06-10
Brief Title:
Iloprost in Preventing Lung Cancer in Patients at High Risk for This Disease
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
A Randomized Phase II Chemoprevention Study of Iloprost Versus Placebo in Patients at High Risk for Lung Cancer
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
OBJECTIVES
Primary
Compare the reversal of premalignant histological changes in the bronchial epithelium of patients at high risk for lung cancer defined by 20 pack years of smoking and sputum atypia treated with iloprost vs placebo
Determine whether this drug modulates Ki-67 proliferation index Antigen Ki-67 in these patients
Determine whether this drug affects prostaglandin metabolism in these patients
Determine the toxicity profile of this drug in these patients
Secondary
Determine whether this drug modulates a panel of biomarkers including MCM-2Minichromosome maintenance protein forms DNA helicase EGFR Epidermal growth factor receptor cell surface receptor for the epidermal growth factor family of proteins Mutations in EGFR expression or activity can result in cancer HER2neu Human epidermal growth factor receptor 2 HER2 is a member of the EGFR family RARĪ² Retinoic Acic Receptor Beta is a nuclear transcription regulator and a member of the thyroid-steroid hormone receptor superfamily p53 FHIT Fragile histidine triad protein is an enzyme involved in purine metabolism and had been demonstrated to be a tumor suppressor apoptotic index and microvessel density in these patients
Determine the genes whose expression is altered by this drug in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to smoking status current vs former and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral iloprost twice daily
Arm II Patients receive oral placebo twice daily In both arms treatment continues for 6 months in the absence of unacceptable toxicity
Patients are followed at 1 month and then annually thereafter
PROJECTED ACCRUAL A total of 152 patients 76 38 current smokers and 38 former smokers per treatment arm will be accrued for this study within 2 years
Primary
Compare the reversal of premalignant histological changes in the bronchial epithelium of patients at high risk for lung cancer defined by 20 pack years of smoking and sputum atypia treated with iloprost vs placebo
Determine whether this drug modulates Ki-67 proliferation index Antigen Ki-67 in these patients
Determine whether this drug affects prostaglandin metabolism in these patients
Determine the toxicity profile of this drug in these patients
Secondary
Determine whether this drug modulates a panel of biomarkers including MCM-2Minichromosome maintenance protein forms DNA helicase EGFR Epidermal growth factor receptor cell surface receptor for the epidermal growth factor family of proteins Mutations in EGFR expression or activity can result in cancer HER2neu Human epidermal growth factor receptor 2 HER2 is a member of the EGFR family RARĪ² Retinoic Acic Receptor Beta is a nuclear transcription regulator and a member of the thyroid-steroid hormone receptor superfamily p53 FHIT Fragile histidine triad protein is an enzyme involved in purine metabolism and had been demonstrated to be a tumor suppressor apoptotic index and microvessel density in these patients
Determine the genes whose expression is altered by this drug in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to smoking status current vs former and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral iloprost twice daily
Arm II Patients receive oral placebo twice daily In both arms treatment continues for 6 months in the absence of unacceptable toxicity
Patients are followed at 1 month and then annually thereafter
PROJECTED ACCRUAL A total of 152 patients 76 38 current smokers and 38 former smokers per treatment arm will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-279 | OTHER | IRB Number from OnCore | None |
| National Cancer Institute | OTHER_GRANT | None | None |