Paclitaxel and Oxaliplatin in Treating Patients With Recurrent or Advanced Non-small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel and oxaliplatin in treating patients who have recurrent or advanced non-small cell lung cancer.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Oxaliplatin in Combination With Paclitaxel in Non-Small Cell Lung Cancer|
- Overall Response Rate [ Time Frame: 4 years ] [ Designated as safety issue: No ]
|Study Start Date:||November 1999|
|Study Completion Date:||August 2003|
|Primary Completion Date:||January 2001 (Final data collection date for primary outcome measure)|
Experimental: Arm A
Paclitaxel 175 mg/m2 : administered by 1-hour constant rate IV infusion through a pump on day 1 of each cycle. Oxaliplatin 130 mg/m2 : On Day 1 of each 21-day treatment cycle, patients receive oxaliplatin diluted in 250-500 mL Dextrose 5% in Water infused intravenously over 2 hours.
|Drug: oxaliplatin Drug: paclitaxel|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004126
|United States, Illinois|
|University of Illinois at Chicago|
|Chicago, Illinois, United States, 60612|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637|
|Louis A. Weiss Memorial Hospital|
|Chicago, Illinois, United States, 60640|
|Cancer Care Specialists of Central Illinois, S.C.|
|Decatur, Illinois, United States, 62526|
|Evanston Northwestern Health Care|
|Evanston, Illinois, United States, 60201|
|Lutheran General Cancer Care Center|
|Park Ridge, Illinois, United States, 60068|
|Oncology/Hematology Associates of Central Illinois, P.C.|
|Peoria, Illinois, United States, 61602|
|Central Illinois Hematology Oncology Center|
|Springfield, Illinois, United States, 62701|
|United States, Indiana|
|Fort Wayne Medical Oncology and Hematology, Inc.|
|Fort Wayne, Indiana, United States, 46885-5099|
|Michiana Hematology/Oncology P.C.|
|South Bend, Indiana, United States, 46617|
|United States, Ohio|
|Arthur G. James Cancer Hospital - Ohio State University|
|Columbus, Ohio, United States, 43210|
|Study Chair:||Ann M. Mauer, MD||University of Chicago|