A Double-Blind, Placebo-Controlled, Parallel Group Study of Uridine 5'-Triphosphate (UTP) Solution for Inhalation as an Adjunct in the Diagnosis of Lung Cancer by Sputum Cytology

Merck Sharp & Dohme LLC0 sites700 target enrollmentApril 2001

ConditionsLung Cancer

DrugsUridine 5'-Triphosphate (UTP) Solution for Inhalation

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Lung Cancer
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 700
Primary Endpoint: Proportion of lung cancers (malignancies) diagnosed by sputum cytology
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The primary objective of this study is to determine if more diagnoses of lung cancer are obtained from the cytological evaluation of sputum expectorated following a single inhaled dose of UTP compared to sputum expectorated following a single inhaled dose of placebo in patients suspected of having lung cancer.

Registry

clinicaltrials.gov

Start Date

April 2001

End Date

December 2003

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•be suspected of having primary lung cancer based upon chest radiograph(s), CT scan(s), or PET scan(s) and with symptom, risk profile, or history suggestive of malignancy
•have FEV1 greater than or equal to 40% predicted normal for age and height

Exclusion Criteria

•have obtained a confirmed diagnosis for the current suspicious lung tumor
•have been treated for the current, suspicious tumor except in cases in which the current lesion is the recurrence of the same tumor (same location) for which treatment was administered no less than 180 days prior to screening
•have undergone a bronchoscopic examination or pulmonary fine needle aspiration biopsy within 4 days prior to dosing, or have undergone sputum induction within 3 days prior to dosing

Outcomes

Primary Outcomes

Proportion of lung cancers (malignancies) diagnosed by sputum cytology

Secondary Outcomes

Wet weight of sputum expectorated;
Proportion of small and large lung cancers diagnosed by sputum cytology;
Proportion of centrally and peripherally located lung cancers diagnosed by sputum cytology;
Proportion of lung cancers of various cell types, stages and resectability diagnosed by sputum cytology;
Macrophage content of sputum