Phase II Study of Oxaliplatin and Navelbine for Second-Line Treatment of Advanced NSCLC.
October 13, 2005 updated by: Integrated Community Oncology Network
Phase II Study of Oxaliplatin in Combination With Navelbine for the Second-Line Treatment of Advanced and Metastatic Non-Small Cell Lung Cancer
The purpose of this study is to determine the response rate to treatment with oxaliplatin and Navelbine in patients with previously treated NSCLC.
Oxaliplatin and Navelbine have not been clinically evaluated yet.
However, Navelbine has been safely administered with other platinum compounds.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
This is a non-randomized trial for patients with previously treated Non-small cell lung cancer.
Each patient will receive 6 cycles of chemotherapy consisting of Oxaliplatin and Navelbine.
Oxaliplatin is given intravenously every 21 days and Navelbine is administered Intravenously on day 1 and day 8 every 21 days.
Study Type
Interventional
Enrollment
40
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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Florida
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Jacksonville, Florida, United States, 32256
- Integrated Community Oncology Network
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Orange Park, Florida, United States, 32073
- Integrated Community Oncology Network
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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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Locally advanced or metastatic non-small cell lung cancer that has recurred, progressed, or failed to respond to previous systemic chemo.
- Measurable disease
- Good performance status (ECOG 0,1 or 2)
Exclusion Criteria:
- Previously treated with Oxaliplatin or Navelbine
- Symptomatic CNS metastases
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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Efficacy
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Secondary Outcome Measures
Outcome Measure |
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Time to progression
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Duration of response
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Survival
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Toxicity profile
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Thomas A Marsland, MD, Integrated Community Oncology Network
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 Registration Dates
First Submitted
October 12, 2005
First Submitted That Met QC Criteria
October 13, 2005
First Posted (Estimate)
October 14, 2005
Study Record Updates
Last Update Posted (Estimate)
October 14, 2005
Last Update Submitted That Met QC Criteria
October 13, 2005
Last Verified
October 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OX-03-087
- ELVIS II
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.