Completed

A Phase II Study of Oxaliplatin in Combination With Paclitaxel in Non-Small Cell Lung Cancer

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What is being tested

oxaliplatin

+ paclitaxel

Drug
Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Lung Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: November 1999
See protocol details

Summary

Principal SponsorUniversity of Chicago
Last updated: February 11, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 1999

Actual date on which the first participant was enrolled.

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.

NCT00004126
Principal SponsorUniversity of Chicago
Last updated: February 11, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

38 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicLung DiseasesNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsCarcinoma, Non-Small-Cell LungLung Neoplasms

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 11 locations

University of Illinois at Chicago

Chicago, United StatesOpen University of Illinois at Chicago in Google Maps

University of Chicago Cancer Research Center

Chicago, United States

Louis A. Weiss Memorial Hospital

Chicago, United States

Cancer Care Specialists of Central Illinois, S.C.

Decatur, United States
Completed11 Study Centers