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

Integrated Community Oncology Network

Status and phase: Unknown; Phase 2

Conditions: Previously Treated Metastatic Non-Small Cell Lung Cancer

Treatments: Drug: Oxaliplatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00238849

ELVIS II

OX-03-087

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)