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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00238849
Recruitment Status : Unknown
Verified October 2005 by Integrated Community Oncology Network.
Recruitment status was:  Not yet recruiting
First Posted : October 14, 2005
Last Update Posted : October 14, 2005
Information provided by:
Integrated Community Oncology Network

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.

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

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  (Clinical Trial)
Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Oxaliplatin

Primary Outcome Measures :
  1. Efficacy

Secondary Outcome Measures :
  1. Time to progression
  2. Duration of response
  3. Survival
  4. Toxicity profile

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00238849

Contact: Diane L Edwards, RN,OCN, CCRP 904-363-7471
Contact: Gloria Perez, RN, BSN, CCRP 904-739-7779

United States, Florida
Integrated Community Oncology Network Not yet recruiting
Jacksonville, Florida, United States, 32256
Contact: Diane Edwards, RN,OCN,CCRP    904-363-7471   
Contact: Gloria Perez, RN,BSN,OCN    904-739-7779   
Integrated Community Oncology Network Not yet recruiting
Orange Park, Florida, United States, 32073
Contact: Carla Malott, RN    904-272-3139   
Contact: Joan Ollie, BSN, RN    904-272-3139   
Principal Investigator: Thomas A Marsland, MD         
Sub-Investigator: Linda S Sylvester, MD         
Sub-Investigator: Kenneth Goldstein, MD         
Sponsors and Collaborators
Integrated Community Oncology Network
Principal Investigator: Thomas A Marsland, MD Integrated Community Oncology Network Identifier: NCT00238849     History of Changes
Other Study ID Numbers: OX-03-087
First Posted: October 14, 2005    Key Record Dates
Last Update Posted: October 14, 2005
Last Verified: October 2005

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

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