Back to resultsPhase II Study of Oxaliplatin and Navelbine for Second-Line Treatment of Advanced NSCLC.
Primary Purpose
Previously Treated Metastatic Non-Small Cell Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oxaliplatin
Sponsored by
About this trial
This is an interventional treatment trial for Previously Treated Metastatic Non-Small Cell Lung Cancer focused on measuring Non-small cell lung cancer
Eligibility Criteria
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
Sites / Locations
- Integrated Community Oncology Network
- Integrated Community Oncology Network
Outcomes
Primary Outcome Measures
Efficacy
Secondary Outcome Measures
Time to progression
Duration of response
Survival
Toxicity profile
Full Information
NCT ID
NCT00238849
First Posted
October 12, 2005
Last Updated
October 13, 2005
Sponsor
Integrated Community Oncology Network
Collaborators
Sanofi
1. Study Identification
Unique Protocol Identification Number
NCT00238849
Brief Title
Phase II Study of Oxaliplatin and Navelbine for Second-Line Treatment of Advanced NSCLC.
Official Title
Phase II Study of Oxaliplatin in Combination With Navelbine for the Second-Line Treatment of Advanced and Metastatic Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2005
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Integrated Community Oncology Network
Collaborators
Sanofi
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Previously Treated Metastatic Non-Small Cell Lung Cancer
Keywords
Non-small cell lung cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Primary Outcome Measure Information:
Title
Efficacy
Secondary Outcome Measure Information:
Title
Time to progression
Title
Duration of response
Title
Survival
Title
Toxicity profile
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diane L Edwards, RN,OCN, CCRP
Phone
904-363-7471
Email
diane.edwards@foa.cc
First Name & Middle Initial & Last Name or Official Title & Degree
Gloria Perez, RN, BSN, CCRP
Phone
904-739-7779
Email
gloria.perez@foa.cc
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas A Marsland, MD
Organizational Affiliation
Integrated Community Oncology Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Integrated Community Oncology Network
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diane Edwards, RN,OCN,CCRP
Phone
904-363-7471
Email
diane.edwards@foa.cc
First Name & Middle Initial & Last Name & Degree
Gloria Perez, RN,BSN,OCN
Phone
904-739-7779
Email
gloria.perez@foa.cc
Facility Name
Integrated Community Oncology Network
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carla Malott, RN
Phone
904-272-3139
Email
carla.malott@foa.cc
First Name & Middle Initial & Last Name & Degree
Joan Ollie, BSN, RN
Phone
904-272-3139
Email
joan.ollie@foa.cc
First Name & Middle Initial & Last Name & Degree
Thomas A Marsland, MD
First Name & Middle Initial & Last Name & Degree
Linda S Sylvester, MD
First Name & Middle Initial & Last Name & Degree
Kenneth Goldstein, MD
12. IPD Sharing Statement
Learn more about this trial
Phase II Study of Oxaliplatin and Navelbine for Second-Line Treatment of Advanced NSCLC.
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