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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Patricia LoRusso, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00914147
First received: June 3, 2009
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Unspecified Adult Solid Tumor, Protocol Specific
Procedure: pulmonary function testing

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pulmonary Function Tests (PFT) in a Phase I Patient Population

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • DLCO, FVC, and FEV1 as measured by pulmonary function testing [ Time Frame: Prior to participation in a Phase I trial ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: May 2009
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Pulmonary Function Test (PFT)
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
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.
Other Name: PFT

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00914147

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Principal Investigator: Patricia M. LoRusso, DO Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Patricia LoRusso, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00914147     History of Changes
Other Study ID Numbers: CDR0000642265, P30CA022453, WSU-2009-004
Study First Received: June 3, 2009
Last Updated: November 21, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Barbara Ann Karmanos Cancer Institute:
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on July 23, 2014