Effects of Carboplatin and Gemcitabine on Stage IIIB Pleural Effusion and Stage IV Lung Cancer - Full Text View

Sponsors and Collaborators:	University of Kentucky Kentucky Lung Cancer Research Program
Information provided by:	University of Kentucky
ClinicalTrials.gov Identifier:	NCT00247416

Purpose

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
Stage IV Non-Small Cell Lung Cancer Stage IIIB-Pleural Effusion	Drug: Gemcitabine Drug: Dexamethasone Drug: Carboplatin	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Gemcitabine hydrochloride Gemcitabine

U.S. FDA Resources

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

Further study details as provided by University of Kentucky:

Primary Outcome Measures:

Determine the effect of dexamethasone pre-treatment on response rates, and survival. [ Time Frame: Pre-treatment, pre-cycles 3 & 5 and 4 weeks after last treatment ] [ Designated as safety issue: No ]
Evaluate the effect of dexamethasone on clinically relevant parameters of hematologic, non-hematologic toxicity and quality of life parameters. [ Time Frame: continuous throughout treatment ] [ Designated as safety issue: Yes ]

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
1: Placebo Comparator No Dexamethasone	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.
2: Experimental Dexamethasone	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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Untreated, stage IIIB with pleural effusion
Untreated, Stage IV, non-small cell lung cancer
Recurrent after surgery if no previous radiation therapy or chemotherapy were administered as part of their primary treatment, except for palliative radiotherapy
18 years of age or older
ECOG PS 0, 1 or 2
At Least one target lesion according to the RECIST Criteria
Adequate organ and marrow function

Exclusion Criteria:

Previous cancer history unless they have had curative treatment completed at least 5 years prior to entry.
No previous radiotherapy, chemotherapy or immunotherapy for NSCLC, except for radiation therapy to the brain to control metastasis, bone to control pain, or lung to relieve bronchial obstruction.
No radiation therapy for any previous cancer to more than 25% of bone marrow.
Uncontrolled, intercurrent illness
Non-study corticosteroids
Pregnant women
Peripheral neuropathy greater than grade 1
Uncontrolled seizures, central nervous system disorders
Major surgery within 4 weeks of the start of study treatment
Lack of complete recovery from major surgery.
Glaucoma
Lack of physical integrity of upper gastrointestinal tract, inability to swallow tablets
Severe acquired or hereditary immunodeficiency
Patients with brain metastases must receive definitive treatment (radiation, surgery or both) and be clinically and radiologically stable for 4 weeks & off corticosteroids for at least 2 weeks prior to randomization.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00247416

Contacts

Contact: John Rinehart, M.D.

(859) 323-6522

john.rinehart@uky.edu

Locations

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

Sponsors and Collaborators

University of Kentucky

Kentucky Lung Cancer Research Program

Investigators

Principal Investigator:

John Rinehart

Lucille P. Markey Cancer Center at University of Kentucky

More Information

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

Keywords provided by University of Kentucky:

Untreated
Lung
Cancer
non-small cell

gemcitabine
gemzar
carboplatin
dexamethasone

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 16, 2009