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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00004126
First received: December 10, 1999
Last updated: February 8, 2013
Last verified: February 2013
  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 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Overall Response Rate [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: November 1999
Study Completion Date: August 2003
Primary Completion Date: January 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Additional Information:
Publications:
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00004126     History of Changes
Other Study ID Numbers: 10014, UCCRC-10014, NCI-T99-0008
Study First Received: December 10, 1999
Last Updated: February 8, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Chicago:
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Oxaliplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 22, 2014