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Study 10 of 2400 for search of: | United States, Kentucky |
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Sponsors and Collaborators: |
University of Kentucky Kentucky Lung Cancer Research Program |
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Information provided by: | University of Kentucky |
ClinicalTrials.gov Identifier: | NCT00247416 |
The purpose of this study is to find better treatment for lung cancer and to find out what effects the combined treatment of carboplatin and gemcitabine when given with or without dexamethasone have on cancer.
This study will determine if dexamethasone, when given before standard chemotherapy will increase the cancer fighting effects and reduce the side effects of chemotherapy.
Condition | Intervention | Phase |
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Stage IV Non-Small Cell Lung Cancer Stage IIIB-Pleural Effusion |
Drug: Gemcitabine Drug: Dexamethasone Drug: Carboplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Phase II Trail of Carboplatin and Gemcitabine Untreated Stage IIIB-Pleural Effusion and Stage IV Lung Cancer |
Estimated Enrollment: | 124 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
No Dexamethasone
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Drug: Gemcitabine
Gemcitabine 1000 mg/m^2 intravenously over 30 minutes on days 5 and 12.
Drug: Carboplatin
AUC 6.0 intravenously over 30 minutes on day 5.
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2: Experimental
Dexamethasone
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Drug: Gemcitabine
Gemcitabine 1000 mg/m^2 intravenously over 30 minutes on days 5 and 12.
Drug: Dexamethasone
16 mg bid for 4 days prior to each chemotherapy start.
Drug: Carboplatin
AUC 6.0 intravenously over 30 minutes on day 5.
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Subjects enrolled in the study will be placed in one of two treatment arms. All subjects have a 50-50 chance of being placed into either treatment arm. Treatment Arm 1 will receive chemotherapy alone, Treatment Arm 2 will receive chemotherapy with dexamethasone given pre-treatment.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: John Rinehart, M.D. | (859) 323-6522 | john.rinehart@uky.edu |
United States, Kentucky | |
Markey Cancer Center | Recruiting |
Lexington, Kentucky, United States, 40536 | |
Contact: John Rinehart, MD 859-323-6522 john.rinehart@uky.edu | |
Principal Investigator: John Rinehart, MD | |
Owensboro Medical HealthCare System | Recruiting |
Owensboro, Kentucky, United States, 42303 | |
Contact: Shawn Sams 270-688-3691 ssams@omhs.org | |
Contact: Jewraj Maheshwari, MD 270-688-3691 | |
Principal Investigator: Jewraj Maheshwari, MD | |
West Kentucky Hematology & Oncology Group, PSC | Recruiting |
Paducah, Kentucky, United States, 42003 | |
Contact: Barbie Beach 270-441-4343 researchnurses@lourdes-pad.org | |
Contact: Harry Carloss, MD 270-441-4343 hcarloss@bellsouth.net | |
Principal Investigator: Harry Carloss, MD | |
Commonwealth Cancer Center | Recruiting |
Danville, Kentucky, United States, 40422 | |
Contact: Julie Jones 859-236-2203 jjones128@bellsouth.net | |
Contact: William John, MD 859-236-2203 wjjohn@bellsouth.net | |
Principal Investigator: William John, MD | |
Brown Cancer Center | Recruiting |
Louisville, Kentucky, United States, 40202 | |
Contact: Jamie Day, RN 502-852-4150 jmluka01@louisville.edu | |
Contact: Goetz Kloecker, MD 502-852-4150 goetzkloecker@yahoo.com | |
Principal Investigator: Goetz Kloecker, MD | |
King's Daughters Medical Center | Withdrawn |
Ashland, Kentucky, United States, 41101 | |
St. Claire Regional Medical Center | Recruiting |
Morehead, Kentucky, United States, 40351 | |
Contact: Mary Horsley 606-783-6476 mahorsley@st-claire.org | |
Contact: Anthony Weaver, MD 606-783-6476 ADWeaver@st-claire.org | |
Principal Investigator: Allen Lim, MD | |
Montgomery Cancer Center | Recruiting |
Mt. Sterling, Kentucky, United States, 40353 | |
Contact: Shelley Weathers 859-499-1000 shelley-rn@hotmail.com | |
Contact: Muhammad Zaydan, MD 859-499-1000 | |
Principal Investigator: Muhammad Zaydan, MD |
Principal Investigator: | John Rinehart | Lucille P. Markey Cancer Center at University of Kentucky |
Responsible Party: | University of Kentucky ( John Rinehart, MD, Associate Professor of Medicine ) |
Study ID Numbers: | CTN-0501 |
Study First Received: | October 28, 2005 |
Last Updated: | June 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00247416 |
Health Authority: | United States: Institutional Review Board |
Untreated Lung Cancer non-small cell |
gemcitabine gemzar carboplatin dexamethasone |
Thoracic Neoplasms Dexamethasone Non-small cell lung cancer Pleural Diseases Carboplatin Carcinoma Pleural Effusion |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Gemcitabine Carcinoma, Non-Small-Cell Lung Dexamethasone acetate Neoplasms, Glandular and Epithelial |
Anti-Inflammatory Agents Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Neoplasms by Site Therapeutic Uses Respiratory Tract Neoplasms |
Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Gastrointestinal Agents Enzyme Inhibitors Glucocorticoids Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Radiation-Sensitizing Agents Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents |