Back to resultsOxaliplatin/CPT-11 for Extensive Stage Small Cell Lung Cancer
Primary Purpose
Small Cell Lung Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Irinotecan (CPT-11)
Oxaliplatin (Eloxatin)
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria: Previously untreated extensive small cell lung cancer No prior chemotherapy No prior radiotherapy except for the treatment of brain metastases Exclusion Criteria: Prior treatment for extensive stage small cell lung cancer Known hypersensitivity to any of the components of oxaliplatin or CPT-11 Greater than grade 2 peripheral neuropathy Known HIV or Hepatitis B or C (active, previously treated or both)
Sites / Locations
- Swedish Medical Center Cancer Institute
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00316433
First Posted
April 18, 2006
Last Updated
April 4, 2007
Sponsor
Swedish Medical Center
Collaborators
Sanofi-Synthelabo
1. Study Identification
Unique Protocol Identification Number
NCT00316433
Brief Title
Oxaliplatin/CPT-11 for Extensive Stage Small Cell Lung Cancer
Official Title
Phase II Study of Oxaliplatin and CPT-11 as First Line Treatment for Extensive Stage Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Terminated
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Swedish Medical Center
Collaborators
Sanofi-Synthelabo
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine the safety and effectiveness of the combination of oxaliplatin and irinotecan (CPT-11) in patients with previously untreated, advanced small cell lung cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
24 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Irinotecan (CPT-11)
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin (Eloxatin)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Previously untreated extensive small cell lung cancer
No prior chemotherapy
No prior radiotherapy except for the treatment of brain metastases
Exclusion Criteria:
Prior treatment for extensive stage small cell lung cancer
Known hypersensitivity to any of the components of oxaliplatin or CPT-11
Greater than grade 2 peripheral neuropathy
Known HIV or Hepatitis B or C (active, previously treated or both)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard (Jack) West, MD
Organizational Affiliation
Swedish Medical Center Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swedish Medical Center Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Oxaliplatin/CPT-11 for Extensive Stage Small Cell Lung Cancer
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