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Pulmonary Function Tests (PFT) in a Phase I Patient Population


N/A
18 Years
N/A
Open (Enrolling)
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Pulmonary Function Tests (PFT) in a Phase I Patient Population


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.

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

DLCO, FVC, and FEV1 as measured by pulmonary function testing

Outcome Time Frame:

Prior to participation in a Phase I trial

Safety Issue:

No

Principal Investigator

Patricia M. LoRusso, DO

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000642265

NCT ID:

NCT00914147

Start Date:

May 2009

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201