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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Department of Defense |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00409968 |
Purpose
This trial is referred to as the "umbrella trial". The BATTLE program consists of this umbrella trial plus four phase II protocols into which the umbrella patients are enrolled. Patients will first enroll in the BATTLE umbrella trial and undergo a tumor biomarker analysis that will be used to assign them to one of the four phase II studies. All patients enrolled in one of the phase II BATTLE protocols must be enrolled in this protocol.
The primary objective of each of the phase II studies will be:
Primary Objectives
• To determine the 8-week progression-free survival rate (i.e. disease control rate) in patients with advanced NSCLC who have failed at least one prior chemotherapy regimen.
Secondary Objectives
| Condition | Intervention |
|---|---|
|
Lung Cancer |
Procedure: Tumor Biopsy |
| Study Type: | Observational |
| Study Design: | Case-Only, Prospective |
| Official Title: | A Biomarker-Integrated Study in Chemorefractory Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) |
A sample of your tumor tissue will be collected for biomarker analysis, and based on the results, you will be assigned to one of four phase II studies.
| Estimated Enrollment: | 250 |
| Study Start Date: | November 2006 |
| Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Screening Study
Screening study to find out if Patients with non-small cell lung cancer (NSCLC) that has spread to other parts of the body are eligible to take part in 1 of 4 different research studies.
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Procedure: Tumor Biopsy
A sample of tumor tissue will be collected by either a CT-guided core biopsy, bronchoscopy, or other type of biopsy (such as subcutaneous, cutaneous, or lymph node).
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients with non-small cell lung cancer (NSCLC) that has spread to other parts of the body.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Christine Alden, BSN | 713-792-0734 |
| United States, Texas | |
| U.T. M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Edward Kim, MD | |
| Principal Investigator: | Edward Kim, MD | U.T. M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Edward Kim, MD/Assistant Professor ) |
| Study ID Numbers: | 2005-0823 |
| Study First Received: | December 8, 2006 |
| Last Updated: | December 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00409968 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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Lung Cancer Non Small Cell Lung Cancer BATTLE Program |
Umbrella Trial Tumor Biopsy NSCLC |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |