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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Procedure: pulmonary function testing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pulmonary Function Test (PFT)<br>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. PFT measurements will be reported as absolute values (e.g. liters) and percentage of predicted. The predicted normal values will be calculated according to sex, age, height and race using the Third National Health and Nutrition Examination Survey (NHANES III) reference equation. Predicted values for diffusion capacity will be calculated using the Morris/Polgar equation. DLCO values will be adjusted to anemia (hemoglobin levels) | Procedure: pulmonary function testing<br>* 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.<br>* Other names: PFT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DLCO, FVC, and FEV1 as measured by pulmonary function testing |  | Prior to participation in a Phase I trial | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific