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Effects of Carboplatin and Gemcitabine on Stage IIIB Pleural Effusion and Stage IV Lung Cancer
This study is currently recruiting participants.
Verified by University of Kentucky, June 2008
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