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

NCT ID: NCT00914147

Last Updated: 2021-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2012-08-23

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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)

Group Type: OTHER

pulmonary function testing

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

PFT

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Barbara Ann Karmanos Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Anthony F. Shields, MD PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ulka N. Vaishampayan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Barbara Ann Karmanos Cancer Institute

Locations

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Countries

United States

Related Links

http://cancer.gov/clinicaltrials

Clinical trial summary from the National Cancer Institute's PDQ® database

Other Identifiers

P30CA022453

Identifier Type: NIH

Identifier Source: secondary_id

View Link

WSU-2009-004

Identifier Type: -

Identifier Source: secondary_id

CDR0000642265

Identifier Type: -

Identifier Source: org_study_id