- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00319514
Weekly Versus 3-Weekly Docetaxel Plus Cisplatin for Advanced NSCLC
March 10, 2008 updated by: Gachon University Gil Medical Center
Randomized Phase II Trial of Two Different Schedules of Docetaxel Plus Cisplatin as First-Line Therapy in Advanced Non-Small Cell Lung Cancer
To evaluate the toxicity and efficacy of docetaxel and cisplatin combination on two schedules in patients with previously untreated, advanced NSCLC.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The combination of docetaxel 75 mg/m2 and cisplatin 60-80 mg/m2 administered every 3 weeks is one of the most commonly used chemotherapy regimen in Korea for the first-line treatment of advanced NSCLC.
Although the 3-weekly regimen is active and tolerated, it is associated with a significant incidence of severe neutropenia, often complicated by fever.
Therefore, there has been increasing interest in the use of a weekly administration of docetaxel as a way of reducing its hematologic toxicity.
We designed this randomized phase II trial to evaluate the safety profile and antitumor activity of two different schedules of docetaxel plus cisplatin given as first-line therapy in patients with advanced NSCLC.
Study Type
Interventional
Enrollment
78
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Incheon, Korea, Republic of, 405 760
- Gachon University Gil Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- histologically or cytologically proven non-small cell lung cancer
- no prior chemotherapy or only adjuvant chemotherapy which had been completed >6 months before registration
- ECOG performance status 0 to 2
- measurable lesion(s)
- normal marrow, hepatic and renal functions
- provision of written informed consent
Exclusion Criteria:
- active infection or severe comorbidities
- history of anaphylaxis of any origin
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Objective response rate
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Secondary Outcome Measures
Outcome Measure |
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Progression-free survival
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Overall survival
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Safety
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Se Hoon Park, MD, Gachon University Gil Medical Center, Incheon, Korea
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2004
Study Completion (Actual)
October 1, 2006
Study Registration Dates
First Submitted
April 28, 2006
First Submitted That Met QC Criteria
April 28, 2006
First Posted (Estimate)
April 27, 2006
Study Record Updates
Last Update Posted (Estimate)
March 12, 2008
Last Update Submitted That Met QC Criteria
March 10, 2008
Last Verified
March 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
Other Study ID Numbers
- GMO-LU-42
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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