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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Previously Treated Metastatic Non-Small Cell Lung Cancer
 Drug: Oxaliplatin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Integrated Community Oncology Network:

Primary Outcome Measures:
  • Efficacy

Secondary Outcome Measures:
  • Time to progression
  • Duration of response
  • Survival
  • Toxicity profile

Estimated Enrollment: 40
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00238849

Contacts
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

Locations
United States, Florida
Integrated Community Oncology Network Not yet recruiting
Jacksonville, Florida, United States, 32256
Contact: Diane Edwards, RN,OCN,CCRP     904-363-7471     diane.edwards@foa.cc    
Contact: Gloria Perez, RN,BSN,OCN     904-739-7779     gloria.perez@foa.cc    
Integrated Community Oncology Network Not yet recruiting
Orange Park, Florida, United States, 32073
Contact: Carla Malott, RN     904-272-3139     carla.malott@foa.cc    
Contact: Joan Ollie, BSN, RN     904-272-3139     joan.ollie@foa.cc    
Principal Investigator: Thomas A Marsland, MD            
Sub-Investigator: Linda S Sylvester, MD            
Sub-Investigator: Kenneth Goldstein, MD            
Sponsors and Collaborators
Integrated Community Oncology Network
Sanofi
Investigators
Principal Investigator: Thomas A Marsland, MD Integrated Community Oncology Network
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00238849     History of Changes
Other Study ID Numbers: OX-03-087, ELVIS II
Study First Received: October 12, 2005
Last Updated: October 13, 2005
Health Authority: United States: Institutional Review Board

Keywords provided by Integrated Community Oncology Network:
Non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Oxaliplatin
Vinorelbine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 16, 2013