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Paclitaxel and Oxaliplatin in Treating Patients With Recurrent or Advanced Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: University of Chicago
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004126
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: oxaliplatin
Drug: paclitaxel
Phase II

MedlinePlus related topics:   Cancer    Lung Cancer   

Drug Information available for:   Paclitaxel    Oxaliplatin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase II Study of Oxaliplatin in Combination With Paclitaxel in Non-Small Cell Lung Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   November 1999

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004126

Locations
United States, Illinois
Cancer Care Specialists of Central Illinois, S.C.    
      Decatur, Illinois, United States, 62526
Central Illinois Hematology Oncology Center    
      Springfield, Illinois, United States, 62701
Evanston Northwestern Health Care    
      Evanston, Illinois, United States, 60201
Louis A. Weiss Memorial Hospital    
      Chicago, Illinois, United States, 60640
Lutheran General Cancer Care Center    
      Park Ridge, Illinois, United States, 60068
Oncology/Hematology Associates of Central Illinois, P.C.    
      Peoria, Illinois, United States, 61602
University of Chicago Cancer Research Center    
      Chicago, Illinois, United States, 60637
University of Illinois at Chicago    
      Chicago, Illinois, United States, 60612
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

Sponsors and Collaborators
University of Chicago
National Cancer Institute (NCI)

Investigators
Study Chair:     Ann M. Mauer, MD     University of Chicago    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000067354, UCCRC-10014, NCI-T99-0008
First Received:   December 10, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00004126
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer  
stage IIIB non-small cell lung cancer  
stage IV non-small cell lung cancer  

Study placed in the following topic categories:
Thoracic Neoplasms
Oxaliplatin
Non-small cell lung cancer
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008




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