Vinorelbine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

January 3, 2014 updated by: GlaxoSmithKline

A Research Study Evaluating Oral and Intravenous NAVELBINE as a Single Agent for the Treatment of Chemotherapy-Naive Subjects With Inoperable Stage IIIb or Stage IV 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. Giving drugs in different ways may kill more tumor cells. It is not yet known whether giving vinorelbine by mouth or infusion is more effective in treating non- small cell lung cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of vinorelbine given by mouth or as an infusion in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Compare the safety and efficacy of oral versus intravenous vinorelbine in patients with stage IIIB or IV non-small cell lung cancer. II. Compare the quality of life of patients treated with these regimens. III. Compare the pharmacokinetics of these treatment regimens in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral vinorelbine weekly. Arm II: Patients receive vinorelbine IV over 10 minutes weekly. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed several times during treatment and 4 weeks after treatment. Patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A maximum of 195 patients will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Oshawa, Ontario, Canada, L1G 2B9
        • Lakeridge Health Oshawa
    • Quebec
      • Montreal, Quebec, Canada, H2W 1S6
        • McGill University
  • Puerto Rico
      • San Juan, Puerto Rico, 00936-5067
        • University of Puerto Rico School of Medicine Medical Sciences Campus
      • San Juan, Puerto Rico, 00927-5800
        • Veterans Affairs Medical Center - San Juan
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Arizona Clinical Research Center
      • Tucson, Arizona, United States, 85723
        • Veterans Affairs Medical Center - Tucson
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Highlands Oncology Group, P.A.
      • Hot Springs, Arkansas, United States, 71913
        • Genesis Cancer Center
    • California
      • Fairfield, California, United States, 94533
        • NorthBay Healthcare System
      • Pomona, California, United States, 91767
        • Wilshire Oncology Medical Center
      • Redding, California, United States, 96009-3100
        • Cancer Care Consultants of Northern California
    • Florida
      • Boca Raton, Florida, United States, 33428
        • Comprehensive Cancer Care Specialists of Boca Raton
      • Pensacola, Florida, United States, 32514
        • West Florida Cancer Institute - Pensacola
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago Cancer Research Center
    • Indiana
      • South Bend, Indiana, United States, 46634
        • South Bend Clinic and SurgiCenter
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Medical Oncology, LLC
      • Lafayette, Louisiana, United States, 70503
        • Office of Luis Alberto Meza
    • Massachusetts
      • Pittsfield, Massachusetts, United States, 01201
        • Berkshire Physicians and Surgeons, P.C.
    • Michigan
      • Detroit, Michigan, United States, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Lansing, Michigan, United States, 48909
        • Sparrow Regional Cancer Center
      • Saint Joseph, Michigan, United States, 49085
        • Lakeland Medical Center - St. Joseph
      • Southfield, Michigan, United States, 48075
        • Providence Hospital Cancer Center
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • St. Luke's Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University Barnard Cancer Center
      • Saint Louis, Missouri, United States, 63141
        • Mercy Oncology-Hematology Limited
    • Nebraska
      • Lincoln, Nebraska, United States, 68510-4844
        • Cancer Resource Center - Lincoln
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756-0002
        • Norris Cotton Cancer Center
    • New Jersey
      • Elizabeth, New Jersey, United States, 07201
        • Trinitas Hospital - Jersey Street Campus
      • Hackensack, New Jersey, United States, 07601
        • Northern NJ Cancer Associates
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Lovelace Health Systems
    • New York
      • Buffalo, New York, United States, 14215
        • Veterans Affairs Medical Center - Buffalo
      • Great Neck, New York, United States, 11022
        • Office of Hal Gerstein
      • New York, New York, United States, 10016
        • NYU School of Medicine's Kaplan Comprehensive Cancer Center
      • New York, New York, United States, 10011
        • Saint Vincents Comprehensive Breast Center
      • Northport, New York, United States, 11768
        • Veterans Affairs Medical Center - Northport
      • Rochester, New York, United States, 14642
        • University of Rochester Cancer Center
    • North Carolina
      • Burlington, North Carolina, United States, 27216
        • Office of Janak K. Choksi
      • Raleigh, North Carolina, United States, 27609
        • Raleigh Hematology/Oncology Associates - Wake Practice
      • Winston-Salem, North Carolina, United States, 27157-1082
        • Comprehensive Cancer Center at Wake Forest University
    • Ohio
      • Cleveland, Ohio, United States, 44106-5065
        • Ireland Cancer Center
      • Columbus, Ohio, United States, 43235
        • Hematology Oncology Consultants Inc
      • Mayfield Heights, Ohio, United States, 44124
        • Hillcrest Hospital
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213-3489
        • University of Pittsburgh Cancer Institute
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Cancer Centers of the Carolinas
    • Tennessee
      • Memphis, Tennessee, United States, 38117
        • West Clinic, P.C.
      • Memphis, Tennessee, United States, 38119
        • Memphis Cancer Center
    • Texas
      • Dallas, Texas, United States, 75235-9154
        • Simmons Cancer Center - Dallas
      • Dallas, Texas, United States, 75243
        • Medical Group of Texas
      • Lubbock, Texas, United States, 79410
        • Joe Arrington Cancer Center
    • Washington
      • Tacoma, Washington, United States, 98405
        • MultiCare Hematolgy/Oncology Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IIIB or IV non-small cell lung cancer not amenable to combination chemotherapy, curative surgery, or radiotherapy Bidimensionally measurable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT less than 2.5 times ULN Alkaline phosphatase less than 5 times ULN (except in cases of bone or liver metastases) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No unstable or uncontrolled cardiac disease Pulmonary: No history of recurrent aspiration pneumonitis within the past 3 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 9 days after study Able to swallow capsules intact No active infection within the past 2 weeks No unstable or uncontrolled medical conditions No other prior malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix No history of peripheral neuropathy with severity greater than CALGB grade 1

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunologic therapy At least 1 week since prior hematopoietic growth factors or other blood products Chemotherapy: See Disease Characteristics No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics At least 2 weeks since prior surgery Other: At least 4 weeks since prior investigational device or drug No other concurrent anticancer therapy No other concurrent investigational device or drug

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Chair: Tess Delacruz, RN, BSN, GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2000

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

June 2, 2000

First Submitted That Met QC Criteria

March 23, 2004

First Posted (Estimate)

March 24, 2004

Study Record Updates

Last Update Posted (Estimate)

January 6, 2014

Last Update Submitted That Met QC Criteria

January 3, 2014

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067897
  • GW-VINA2004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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