Pilot Study for the Determination of Tumor Response to Chemotherapy in Advanced NSCLC Through Gene Expression Profiling

• Status: Terminated
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan Cancer Center; University of Michigan Rogel Cancer Center
• Treatments: Carboplatin; Paclitaxel

Criteria

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.