Clinical trial NCT00914147: Lung Function Testing in Patients With Locally Advanced or Metastatic Solid Tumors
Official title: Pulmonary Function Tests (PFT) in a Phase I Patient Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-06-04
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: DLCO, FVC, and FEV1 as measured by pulmonary function testing
timeFrame: Prior to participation in a Phase I trial
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Ulka N. Vaishampayan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: