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

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

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.

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.

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