A Phase II Study of Oxaliplatin in Combination With Paclitaxel in Non-Small Cell Lung Cancer
OBJECTIVES: I. Determine the overall, partial, and complete response rates in patients with
advanced non-small cell lung cancer treated with oxaliplatin plus paclitaxel. II. Assess the
overall survival, time to tumor progression, and toxicities associated with this combination
regimen in this patient population. III. Assess the neurologic toxicity of this combination
regimen and its correlation with creatinine clearance in these patients.
OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 1 hour followed by
oxaliplatin IV over 2 hours on day 1. Treatment repeats every 3 weeks in the absence of
disease progression or unacceptable toxicity. Patients are followed for at least 2 years or
until death.
PROJECTED ACCRUAL: Approximately 17-37 patients will be accrued for this study within 24
months.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate
4 years
No
Ann M. Mauer, MD
Study Chair
University of Chicago
United States: Federal Government
10014
NCT00004126
November 1999
August 2003
Name | Location |
---|---|
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
Lutheran General Cancer Care Center | Park Ridge, Illinois 60068 |
Evanston Northwestern Health Care | Evanston, Illinois 60201 |
Louis A. Weiss Memorial Hospital | Chicago, Illinois 60640 |
University of Illinois at Chicago | Chicago, Illinois 60612 |
Cancer Care Specialists of Central Illinois, S.C. | Decatur, Illinois 62526 |
Oncology/Hematology Associates of Central Illinois, P.C. | Peoria, Illinois 61602 |
Central Illinois Hematology Oncology Center | Springfield, Illinois 62701 |
Fort Wayne Medical Oncology and Hematology, Inc. | Fort Wayne, Indiana 46885-5099 |
Michiana Hematology/Oncology P.C. | South Bend, Indiana 46617 |