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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute National Cancer Institute (NCI) |
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Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT00226590 |
This is a single institution Phase II study for patients with unresectable Stage IIIA and IIIB non-small cell lung cancer. The treatment starts with 2 cycles of gemcitabine and carboplatin followed by concurrent chemotherapy with radiation. The chemoradiation includes using paclitaxel and carboplatin with daily thoracic radiation to a total dose of 74 Gy. Response rate will be determined following the chemotherapy with gemcitabine and carboplatin and evaluated again after the chemoradiation. Treatment toxicities will also be assessed.
Condition | Intervention | Phase |
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Carcinoma, Non-Small-Cell Lung |
Drug: Gemcitabine Drug: Carboplatin Drug: Paclitaxel Procedure: radiation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Trial of Induction Gemcitabine and Carboplatin Followed by Paclitaxel and Carboplatin With Concurrent Thoracic Radiation for Patients With Unresectable Stage IIIA/IIIB Non-Small Cell Lung Cancer. |
Estimated Enrollment: | 150 |
Study Start Date: | April 2003 |
In this trial we will adopt the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy. Substitution of gemcitabine for paclitaxel in the induction chemotherapy will allow us to evaluate the impact of RRM1 expression on the activity of this agent. The expression of RRM1 will be evaluated prior to initiation of therapy, following induction chemotherapy but prior to concurrent chemoradiation, and following completion of all therapy by CT-guided core needle biopsies. This is a single institution phase II clinical trial, of induction treatment with gemcitabine and carboplatin followed by concurrent chemoradiation using paclitaxel and carboplatin and daily thoracic radiation to a total dose of 74 Gy for patients with unresectable Stage IIIA and IIIB NSCLC. The specific clinical objectives of this study are as follows:To determine the response rate (both CT and PET assessment) to two cycles of induction chemotherapy with gemcitabine and carboplatin; To determine the response rate (both CT and PET assessment) to concurrent thoracic radiation and weekly paclitaxel and carboplatin; To evaluate the patterns of local and distant failure for patients treated with induction chemotherapy followed by concurrent chemoradiation according to this regimen; To estimate the median, 1 year, and overall survival; To assess acute and long term toxicities of treatment.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Eligibility Criteria:
United States, Florida | |
H. Lee Moffitt Cancer Center & Research Insitute | |
Tampa, Florida, United States, 33612 |
Principal Investigator: | Gerold Bepler, MD, PhD | H. Lee Moffitt Cancer Center and Research Institute |
Study ID Numbers: | MCC-13240 |
Study First Received: | September 23, 2005 |
Last Updated: | May 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00226590 |
Health Authority: | United States: Food and Drug Administration |
Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Paclitaxel Lung Neoplasms Lung Diseases |
Carboplatin Gemcitabine Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Antimetabolites Respiratory Tract Neoplasms Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Enzyme Inhibitors |
Antimitotic Agents Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic |