Effects of Carboplatin and Gemcitabine on Stage IIIB Pleural Effusion and Stage IV Lung Cancer
Randomized Phase II Trail of Carboplatin and Gemcitabine Untreated Stage IIIB-pleural Effusion and Stage IV Lung Cancer
1 other identifier
interventional
60
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2005
Typical duration for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 28, 2005
CompletedFirst Posted
Study publicly available on registry
November 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
March 7, 2014
CompletedMarch 7, 2014
January 1, 2014
3.9 years
October 28, 2005
August 2, 2013
January 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Reduction in Grade 3/4 Neutropenia
Reduction grade 3/4 neutropenia
continuous throughout treatment, up to 25 weeks
Secondary Outcomes (3)
Effect of Dexamethasone Pre-treatment on Response Rate.
Pre-treatment, pre-cycles 3 & 5, and up to 4 weeks after last treatment
Effect of Dexamethasone Pre-treatment on Overall Survival.
Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, every 3 months, an average of 471 days
Progression-free Survival
Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, and every 3 months, an average of 471 days
Study Arms (2)
1 No Dex
OTHERNo Dexamethasone
2 Dex
EXPERIMENTALDexamethasone
Interventions
Gemcitabine 1000 mg/m\^2 intravenously over 30 minutes on days 5 and 12.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Susanne Arnoldlead
- Kentucky Lung Cancer Research Programcollaborator
Study Sites (7)
Commonwealth Cancer Center
Danville, Kentucky, 40422, United States
Markey Cancer Center
Lexington, Kentucky, 40536, United States
Brown Cancer Center
Louisville, Kentucky, 40202, United States
St. Claire Regional Medical Center
Morehead, Kentucky, 40351, United States
Montgomery Cancer Center
Mount Sterling, Kentucky, 40353, United States
Owensboro Medical HealthCare System
Owensboro, Kentucky, 42303, United States
West Kentucky Hematology & Oncology Group, PSC
Paducah, Kentucky, 42003, United States
Related Publications (1)
Rinehart J, Arnold S, Kloecker G, Lim A, Zaydan MA, Baeker T, Maheshwari JG, Carloss H, Slone S, Shelton B, Croley J, Kvale E, Brooks M, Leggas M. Phase II randomized trial of carboplatin and gemcitabine with or without dexamethasone pre-treatment in patients with Stage IV non-small cell lung cancer. Cancer Chemother Pharmacol. 2013 May;71(5):1375-83. doi: 10.1007/s00280-013-2111-3. Epub 2013 Mar 9.
PMID: 23475103RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Suzane Arnold, MD
- Organization
- University of Kentucky Markey Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
John Rinehart
Lucille P. Markey Cancer Center at University of Kentucky
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sponsor/Investigator
Study Record Dates
First Submitted
October 28, 2005
First Posted
November 1, 2005
Study Start
August 1, 2005
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
March 7, 2014
Results First Posted
March 7, 2014
Record last verified: 2014-01