Status:
COMPLETED
Preoperative Therapy in Patients With Stages IB, II, IIIA, and Selected IIIB Patients With Non-Small Cell Lung Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Aventis Pharmaceuticals
Eli Lilly and Company
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This trial is designed to study the role of docetaxel/gemcitabine, an active and relatively non-toxic combination in advanced NSCLC. This study will help to better define optimal preoperative regimens...
Detailed Description
Upon determination of eligibility, patients will receive: Pre-operative * Docetaxel * Gemcitabine Post-operative * Docetaxel * Carboplatin * Radiation Therapy Patients with stage IB and II NSCLC wh...
Eligibility Criteria
Inclusion
- To be included in this study, you must meet the following criteria:
- Histologically confirmed non-small cell lung cancer
- Must be operable candidate
- Clinical stage IB, II, and select III non-small cell lung cancer are eligible
- Measurable or evaluable disease
- Able to perform activities of daily living with minimal assistance
- Must be \> 18 years of age
- Adequate bone marrow, liver or kidney
- No previous chemotherapy or radiation therapy for non-small cell lung cancer
- Moderate to severe peripheral neuropathy
- Understand the nature of this study and give written informed consent.
Exclusion
- You cannot participate in this study if any of the following apply to you:
- Stage IV disease
- History of prior malignancy within five years
- Women who are pregnant or breast-feeding
- Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00193427
Start Date
April 1 2004
End Date
December 1 2008
Last Update
March 3 2022
Active Locations (1)
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1
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023