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

Previously Treated Metastatic Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00238849
• Other study ID #: OX-03-087
• Secondary ID: ELVIS II
• Status: Not yet recruiting
• Phase: Phase 2
• First received: October 12, 2005
• Last updated: October 13, 2005

Study information

• Verified date: October 2005
• Source: Integrated Community Oncology Network
• Contact: Diane L Edwards, RN,OCN, CCRP
• Phone: 904-363-7471
• Email: diane.edwards[@]foa.cc
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Previously Treated Metastatic Non-Small Cell Lung Cancer

Intervention

Drug:
• Oxaliplatin

Locations

Country	Name	City	State
United States	Integrated Community Oncology Network	Jacksonville	Florida
United States	Integrated Community Oncology Network	Orange Park	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Integrated Community Oncology Network	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy
Secondary	Time to progression
Secondary	Duration of response
Secondary	Survival
Secondary	Toxicity profile