Status:
COMPLETED
Lung Function Testing in Patients With Locally Advanced or Metastatic Solid Tumors
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18-120 years
Phase:
NA
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 ...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2012
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00914147
Start Date
May 1 2009
End Date
August 23 2012
Last Update
March 8 2021
Active Locations (1)
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1
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379