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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005865
• Other study ID #: CDR0000067897
• Secondary ID: GW-VINA2004
• Status: Completed
• Phase: Phase 2
• First received: June 2, 2000
• Last updated: January 3, 2014
• Start date: April 2000
• Est. completion date: June 2007

Study information

• Verified date: June 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• vinorelbine tartrate

Locations

Country	Name	City	State
Canada	McGill University	Montreal	Quebec
Canada	Lakeridge Health Oshawa	Oshawa	Ontario
Puerto Rico	University of Puerto Rico School of Medicine Medical Sciences Campus	San Juan
Puerto Rico	Veterans Affairs Medical Center - San Juan	San Juan
United States	Lovelace Health Systems	Albuquerque	New Mexico
United States	Medical Oncology, LLC	Baton Rouge	Louisiana
United States	Comprehensive Cancer Care Specialists of Boca Raton	Boca Raton	Florida
United States	Veterans Affairs Medical Center - Buffalo	Buffalo	New York
United States	Office of Janak K. Choksi	Burlington	North Carolina
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Hematology Oncology Consultants Inc	Columbus	Ohio
United States	Medical Group of Texas	Dallas	Texas
United States	Simmons Cancer Center - Dallas	Dallas	Texas
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	St. Luke's Hospital	Duluth	Minnesota
United States	Trinitas Hospital - Jersey Street Campus	Elizabeth	New Jersey
United States	NorthBay Healthcare System	Fairfield	California
United States	Highlands Oncology Group, P.A.	Fayetteville	Arkansas
United States	Office of Hal Gerstein	Great Neck	New York
United States	Cancer Centers of the Carolinas	Greenville	South Carolina
United States	Northern NJ Cancer Associates	Hackensack	New Jersey
United States	Genesis Cancer Center	Hot Springs	Arkansas
United States	Office of Luis Alberto Meza	Lafayette	Louisiana
United States	Sparrow Regional Cancer Center	Lansing	Michigan
United States	Norris Cotton Cancer Center	Lebanon	New Hampshire
United States	Cancer Resource Center - Lincoln	Lincoln	Nebraska
United States	Joe Arrington Cancer Center	Lubbock	Texas
United States	HillCrest Hospital	Mayfield Heights	Ohio
United States	Memphis Cancer Center	Memphis	Tennessee
United States	West Clinic, P.C.	Memphis	Tennessee
United States	NYU School of Medicine's Kaplan Comprehensive Cancer Center	New York	New York
United States	Saint Vincents Comprehensive Breast Center	New York	New York
United States	Veterans Affairs Medical Center - Northport	Northport	New York
United States	West Florida Cancer Institute - Pensacola	Pensacola	Florida
United States	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	Berkshire Physicians and Surgeons, P.C.	Pittsfield	Massachusetts
United States	Wilshire Oncology Medical Center	Pomona	California
United States	Raleigh Hematology/Oncology Associates - Wake Practice	Raleigh	North Carolina
United States	Cancer Care Consultants of Northern California	Redding	California
United States	University of Rochester Cancer Center	Rochester	New York
United States	Lakeland Medical Center - St. Joseph	Saint Joseph	Michigan
United States	Mercy Oncology-Hematology Limited	Saint Louis	Missouri
United States	Washington University Barnard Cancer Center	Saint Louis	Missouri
United States	South Bend Clinic and SurgiCenter	South Bend	Indiana
United States	Providence Hospital Cancer Center	Southfield	Michigan
United States	MultiCare Hematolgy/Oncology Clinic	Tacoma	Washington
United States	Arizona Clinical Research Center	Tucson	Arizona
United States	Veterans Affairs Medical Center - Tucson	Tucson	Arizona
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

References & Publications (1)

Hirsh V, Desjardins P, Needles BM, Rigas JR, Jahanzeb M, Nguyen L, Zembryki D, Leopold LH. Oral versus intravenous administration of vinorelbine as a single agent for the first-line treatment of metastatic nonsmall cell lung carcinoma (NSCLC): A randomize — View Citation