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Home > "P" Clinical Trials Conditions > Paclitaxel and Oxaliplatin in Treating Patients With Recurrent or Advanced Non-small Cell Lung Cancer  Paclitaxel and Oxaliplatin in Treating Patients With Recurrent or Advanced Non-small Cell Lung Cancer
Paclitaxel and Oxaliplatin in Treating Patients With Recurrent or Advanced Non-small Cell Lung Cancer
For Condition: recurrent non-small cell lung cancer,stage 3B non-small cell lung cancer,stage 4 non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , University of Chicago Cancer Research Center
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed non-small cell lung cancer (NSCLC); Stage IIIB with pleural effusion OR Stage IV OR Recurrent disease - Bidimensionally measurable disease --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy for advanced NSCLC; At least 4 weeks since prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: At least 4 weeks since prior radiotherapy - Surgery: Not specified - Other: No other concurrent investigational agents; No concurrent antiretroviral therapy for HIV positive patients --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2; Karnofsky 50-100% - Life expectancy: Not specified - Hematopoietic: WBC greater than 3,000/mm3; Absolute neutrophil count at least 1,500/mm3; Platelet count greater than 100,000/mm3 - Hepatic: Bilirubin normal SGOT less than 2 times normal - Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min; BUN less than 1.5 times normal - Cardiovascular: No symptomatic congestive heart failure; No unstable angina or myocardial infarction within the past 6 months; No evidence of heart block greater than first degree, bundle branch block, or ventricular or supraventricular arrhythmia - Other: No allergy to platinum compounds or antiemetics appropriate for study; No other uncontrolled illness; No active or ongoing infection; No evidence of peripheral neuropathy by physical exam or history; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 6 months after study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AnnMauer, Study Chair, University of Chicago Cancer Research Center
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, 62701
United States
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois, 62526
United States
Evanston Northwestern Health Care
Evanston, Illinois, 60201
United States
University of Illinois at Chicago
Chicago, Illinois, 60612
United States
Lutheran General Cancer Care Center
Park Ridge, Illinois, 60068
United States
Fort Wayne Medical Oncology and Hematology, Inc.
Ft. Wayne, Indiana, 46885-5099
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210
United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61602
United States
Michiana Hematology/Oncology P.C.
South Bend, Indiana, 46617
United States
Additional Information:
Study ID Numbers: CDR0000067354; UCCRC-10014,NCI-T99-0008
Study Start Date: January 2001
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004126
Other Recurrent Non-Small Cell Lung Cancer Studies:
1. Gene Therapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
2. Phase I/II Study of Cetuximab, Gemcitabine, and Carboplatin in Patients With Chemotherapy-Naive Stage IV Non-Small Cell Lung Cancer
3. Arsenic Trioxide in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
4. Intravenous Interleukin-4 PE38KDEL Cytotoxin in Treating Patients With Recurrent or Metastatic Kidney Cancer, Non-Small Cell Lung Cancer, or Breast Cancer
5. Bortezomib Plus Gemcitabine and Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
Related Studies:
Other recurrent non-small cell lung cancer Clinical Trials
Other Illinois Clinical Trials
Other Evanston Clinical Trials
Paclitaxel and Oxaliplatin in Treating Patients With Recurrent or Advanced Non-small Cell Lung Cancer
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