Advanced Non-Small Cell Lung Cancer Clinical Trial
Official title:
Pilot Study for the Determination of Tumor Response to Chemotherapy in Advanced Non-Small Cell Lung Cancer Through Gene Expression Profiling.
Patients who are at least 18 years of age and have a type of cancer known as advanced
non-small cell lung cancer may be eligible for this study if they meet all of the
inclusion/exclusion criteria.
Background: The standard treatment for patients with advanced non-small cell cancer is
chemotherapy. The two drug combination, carboplatin (Paraplatin) and paclitaxel (Taxol), is
commonly used as the first treatment. Unfortunately, standard treatment with chemotherapy
only shrinks the cancer in about 30% of patients that receive it. There is no way to predict
who will or won't benefit from this treatment. The researchers at the University of Michigan
would like to determine if the genes of the lung cancers in patients enrolled in this study
will help predict whether or not the tumors shrink when exposed to standard chemotherapy.
The goal is to find a set of lung cancer genes that will predict successful treatment with
carboplatin and paclitaxel in patients with non-small cell lung cancer.
The actual treatment, carboplatin and paclitaxel, involved in this study is not
experimental. The experimental aspect of this study is the identification of predictors of
response to treatment. To do this, it would require a sample of your cancer. If your initial
surgery or biopsy was done at the University of Michigan, we may already have an adequate
sample of your cancer that could be used for this research. In that case, we are asking for
your permission to use this sample for this study. However, if you meet all eligibility
criteria and agree to participate in this research study and an adequate sample is not
available, you will need to undergo another biopsy procedure for us to obtain a sample of
your cancer. Obtaining a tumor sample is the most crucial part of this research study.
Status | Terminated |
Enrollment | 1 |
Est. completion date | August 2006 |
Est. primary completion date | August 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: histologic or cytologic evidence of stage IIIB (with malignant pleural
effusion) or stage IV NSCLC; no prior chemotherapy; measurable disease; disease that is
amenable to biopsy; age 18 years; Zubrod performance status 0-2; adequate bone marrow,
hepatic and renal function; signed informed consent. Exclusion Criteria: prior chemotherapy or radiation therapy to target lesions; pregnant or lactating women; symptomatic or uncontrolled CNS metastases. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The ultimate goal of this study is to identify a tumor molecular profile using gene expression microarray data that is associated with responsiveness to carboplatin and paclitaxel. | |||
Secondary | To assess the feasibility of accruing patients with advanced non-small cell lung cancer (NSCLC) to a trial that requires pre-treatment biopsies. |
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