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Trial record 60 of 1118 for:    Oral Cancer | ( Map: Canada )

Neoadjuvant Finasteride for Patients With Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02055170
Recruitment Status : Terminated (Unable to improve on poor accrual to study.)
First Posted : February 5, 2014
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
CancerCare Manitoba

Brief Summary:

The purpose of this study is to study the effect of hormone therapies (androgen pathway modification) on the outcomes of patients with lung cancer. This information may be of benefit for future treatment strategies, prevention and control.

In this study, the protein where testosterone binds, called the androgen receptor (AR), will be measured in samples from the patient's biopsy and surgical tumor samples. The investigators will look at a marker of how fast the cancer is growing (Ki67) before using finasteride from your biopsy specimen. Finasteride will be taken from the day of consent until the day of the patient's surgery. This marker will be measured again after using finasteride from the surgical specimen. The investigators will be looking for a decrease in the Ki67 from the patient's biopsy specimen to the surgical specimen as an indicator that this medication is blocking tumour growth.


Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: finasteride 5mg oral daily Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Finasteride for Patients With Non-small Cell Lung Cancer
Study Start Date : June 2014
Actual Primary Completion Date : March 27, 2018
Actual Study Completion Date : March 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Finasteride

Arm Intervention/treatment
Experimental: finasteride
finasteride 5mg po od from study entry to date of surgery
Drug: finasteride 5mg oral daily



Primary Outcome Measures :
  1. Change in proliferation [ Time Frame: Original biopsy to surgical specimen (approx 6 weeks) ]
    Patients will be followed from time of consent (around the time of consultation with a Thoracic Surgeon) to date of surgery (on average, approximately 4-6 weeks following Thoracic Surgeon consultation).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male
  • age >18
  • biopsy-proven non-small cell lung cancer
  • surgical intervention planned

Exclusion Criteria:

  • current use of 5-alpha reductase inhibitor
  • previous diagnosis of prostate cancer
  • previous hypersensitivity to 5-alpha reductase inhibitor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055170


Locations
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Canada, Manitoba
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A1R9
Sponsors and Collaborators
CancerCare Manitoba

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Responsible Party: CancerCare Manitoba
ClinicalTrials.gov Identifier: NCT02055170     History of Changes
Other Study ID Numbers: HLC001
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Bronchial Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Finasteride
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Urological Agents