Skip to content

Lung Function Testing in Patients With Locally Advanced or Metastatic Solid Tumors

Pulmonary Function Tests (PFT) in a Phase I Patient Population

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00914147
Enrollment
48
Registered
2009-06-04
Start date
2009-05-31
Completion date
2012-08-23
Last updated
2021-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Brief summary

RATIONALE: Measuring how well the lungs work in patients with cancer may help doctors predict how patients will respond to treatment and help plan the best treatment. PURPOSE: This clinical trial is studying lung function testing in patients with locally advanced or metastatic solid tumors.

Detailed description

OBJECTIVES: Primary * 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% confidence. Secondary * 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.

Interventions

After signing consent, patients will undergo a complete spirometry test, lung volumes and diffusing capacity (DLCO) measurement utilizing the single-breath breath holding technique, according to the ATS/ERS consensus and standardization.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Barbara Ann Karmanos Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically confirmed solid tumor * Locally advanced or metastatic disease * Disease progressed on or after standard therapy OR there is no standard therapy for the malignancy * Standard therapy is defined as first- or second-line therapy that has been shown to provide clinical benefit * Life-long non-smoker * No lung metastasis and/or pleural effusion causing signs or symptoms that impact patient performance status PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Body mass index ≤ 35 * No concurrent uncontrolled illness including, but not limited to, the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Ventricular arrhythmia * Psychiatric illness or social situation that would limit compliance with study requirements * No uncontrolled chest or abdominal pain * No oral or facial pain exacerbated by an oral device * No stress incontinence * No COPD, interstitial lung disease, pulmonary embolism, or hemorrhage within the past 6 months * No history of pulmonary fibrosis or pulmonary hypertension * No oxygen requirement at baseline * No asthma * No occupational lung disease, including, but not limited to, asbestos exposure * No polycythemia * No history of connective tissue disease PRIOR CONCURRENT THERAPY: * No prior radiotherapy to the lung * At least 6 months since prior lung surgery * No prior amiodarone hydrochloride * No prior high-dose chemotherapy with autologous or allogeneic hematopoietic stem cell transplantation * No concurrent combination antiretroviral therapy for HIV-positive patients

Design outcomes

Primary

MeasureTime frame
DLCO, FVC, and FEV1 as measured by pulmonary function testingPrior to participation in a Phase I trial

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026