Pulmonary Function Tests (PFT) in a Phase I Patient Population
- To obtain the distribution of DLCO, FVC, and FEV_1 by pulmonary function testing (PFT)
in patients with heavily pretreated locally advanced or metastatic solid tumors
referred to the Karmanos Cancer Institute (KCI) Phase I Clinical Trials Program.
- To estimate the mean DLCO to within 4 units (% of predicted) of the true mean with 95%
- To estimate the percentage of patients who meet the defined eligibility criteria
(including PFT levels, especially DLCO) from the entire population enrolled in the KCI
Phase I Clinical Trials Program.
OUTLINE: Patients undergo pulmonary function testing comprising spirometry test, lung
volumes, and DLCO measurement utilizing the single-breath breath-holding technique. Patients
then proceed to treatment on a phase I clinical trial.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
DLCO, FVC, and FEV1 as measured by pulmonary function testing
Prior to participation in a Phase I trial
Patricia M. LoRusso, DO
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|