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Lung Function Testing in Patients With Locally Advanced or Metastatic Solid Tumors
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), May 2009
First Received: June 3, 2009   No Changes Posted
Sponsors and Collaborators: Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00914147
  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: Diagnostic
Official Title: Pulmonary Function Tests (PFT) in a Phase I Patient Population

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • DLCO, FVC, and FEV1 as measured by pulmonary function testing [ Designated as safety issue: No ]

Estimated Enrollment: 52
Study Start Date: May 2009
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00914147

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201-1379
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute     313-576-9363        
Sinai-Grace Hospital Recruiting
Detroit, Michigan, United States, 48235
Contact: Priscila H Goncalves     313-966-3300        
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: Barbara Ann Karmanos Cancer Institute ( Patricia M. LoRusso )
Study ID Numbers: CDR0000642265, WSU-2009-004
Study First Received: June 3, 2009
Last Updated: June 3, 2009
ClinicalTrials.gov Identifier: NCT00914147     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on September 03, 2009