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| Sponsors and Collaborators: |
Sarah Cannon Research Institute Aventis Pharmaceuticals Eli Lilly and Company |
|---|---|
| Information provided by: | Sarah Cannon Research Institute |
| ClinicalTrials.gov Identifier: | NCT00193427 |
Purpose
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 for patients with resectable NSCLC. Since both of these drugs are potent radio-sensitizers, the concurrent use with radiation therapy at these weekly doses may produce not only radio-sensitization, but also considerable antitumor efficacy.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: Docetaxel Drug: Gemcitabine Drug: Carboplatin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase II Trial of Preoperative (Neo-Adjuvant) Therapy in Patients With Stages IB, II, IIIA, and Selected IIIB Patients With Non-Small Cell Lung Cancer |
| Estimated Enrollment: | 80 |
| Study Start Date: | April 2004 |
Upon determination of eligibility, patients will receive:
Pre-operative
Patients with stage IB and II NSCLC who achieved clear margins will not receive any further therapy. Patients with incomplete resection, resection margins of a T3 tumor that are positive or close, stage IIIA AND IIIB NSCLC or disease judged unresectable after preoperative chemotherapy will receive postoperative treatment
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
To be included in this study, you must meet the following criteria:
Exclusion Criteria:
You cannot participate in this study if any of the following apply to you:
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.
Contacts and Locations| United States, Tennessee | |
| Tennessee Oncology, PLLC | |
| Nashville, Tennessee, United States, 37023 | |
| Principal Investigator: | David R. Spigel, MD | Sarah Cannon Research Institute |
More Information
| Study ID Numbers: | SCRI LUN 76, IIT 12180, B9E-US-X425 |
| Study First Received: | September 12, 2005 |
| Last Updated: | October 15, 2007 |
| ClinicalTrials.gov Identifier: | NCT00193427 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Antimetabolites Thoracic Neoplasms Immunologic Factors Adjuvants, Immunologic Carboplatin Immunosuppressive Agents Antiviral Agents Carcinoma Docetaxel Oxymetazoline |
Radiation-Sensitizing Agents Respiratory Tract Diseases Lung Neoplasms Phenylephrine Lung Diseases Non-small Cell Lung Cancer Gemcitabine Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
|
Thoracic Neoplasms Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Gemcitabine |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Enzyme Inhibitors Carboplatin Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms Radiation-Sensitizing Agents Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
