Phase II Study of Oxaliplatin and Navelbine for Second-Line Treatment of Advanced NSCLC.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2005 by Integrated Community Oncology Network.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Sanofi
Information provided by:
Integrated Community Oncology Network
ClinicalTrials.gov Identifier:
NCT00238849
First received: October 12, 2005
Last updated: October 13, 2005
Last verified: October 2005

October 12, 2005
October 13, 2005
Not Provided
Not Provided
Efficacy
Same as current
Complete list of historical versions of study NCT00238849 on ClinicalTrials.gov Archive Site
  • Time to progression
  • Duration of response
  • Survival
  • Toxicity profile
Same as current
Not Provided
Not Provided
 
Phase II Study of Oxaliplatin and Navelbine for Second-Line Treatment of Advanced NSCLC.
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Previously Treated Metastatic Non-Small Cell Lung Cancer
Drug: Oxaliplatin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
Not Provided
Not Provided

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
Both
18 Years and older
No
Contact: Diane L Edwards, RN,OCN, CCRP 904-363-7471 diane.edwards@foa.cc
Contact: Gloria Perez, RN, BSN, CCRP 904-739-7779 gloria.perez@foa.cc
United States
 
NCT00238849
OX-03-087, ELVIS II
Not Provided
Not Provided
Integrated Community Oncology Network
Sanofi
Principal Investigator: Thomas A Marsland, MD Integrated Community Oncology Network
Integrated Community Oncology Network
October 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP