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

NCT00161278 | Terminated Phase 2 DMC

• 1 other identifier: UMCC 2004.058
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To assess the feasibility of accruing patients with advanced non-small cell lung cancer (NSCLC) to a trial that requires pre-treatment biopsies.

Interventions

Carboplatin DRUG

Paclitaxel DRUG

Gene expression profiling (analysis) of tumor samples PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

Carboplatin; Paclitaxel; Gene Expression Profiling

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Genetic Techniques; Investigative Techniques

Study Officials

• Greg Kalemkerian, MD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: December 1, 2004
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: July 30, 2008

Record last verified: 2008-07

Locations

US (1)