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

Phase 2
Conditions
Previously Treated Metastatic Non-Small Cell Lung Cancer
Registration Number
NCT00238849
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
40
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

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Efficacy
Secondary Outcome Measures
NameTimeMethod
Time to progression
Duration of response
Survival
Toxicity profile

Trial Locations

Locations (1)

Integrated Community Oncology Network

🇺🇸

Orange Park, Florida, United States

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