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

NCT00005865 | Completed Phase 2

• 2 other identifiers: CDR0000067897GW-VINA2004
• Study Type: interventional
• Target: N/A
• Locations: 3 countries
• Sites: 50

Brief 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.

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Interventions

vinorelbine tartrate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (50)

Arizona Clinical Research Center

Tucson, Arizona, 85712, United States

Location

Veterans Affairs Medical Center - Tucson

Tucson, Arizona, 85723, United States

Location

Highlands Oncology Group, P.A.

Fayetteville, Arkansas, 72703, United States

Location

Genesis Cancer Center

Hot Springs, Arkansas, 71913, United States

Location

NorthBay Healthcare System

Fairfield, California, 94533, United States

Location

Wilshire Oncology Medical Center

Pomona, California, 91767, United States

Location

Cancer Care Consultants of Northern California

Redding, California, 96009-3100, United States

Location

Comprehensive Cancer Care Specialists of Boca Raton

Boca Raton, Florida, 33428, United States

Location

West Florida Cancer Institute - Pensacola

Pensacola, Florida, 32514, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

South Bend Clinic and SurgiCenter

South Bend, Indiana, 46634, United States

Location

Medical Oncology, LLC

Baton Rouge, Louisiana, 70808, United States

Location

Office of Luis Alberto Meza

Lafayette, Louisiana, 70503, United States

Location

Berkshire Physicians and Surgeons, P.C.

Pittsfield, Massachusetts, 01201, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Sparrow Regional Cancer Center

Lansing, Michigan, 48909, United States

Location

Lakeland Medical Center - St. Joseph

Saint Joseph, Michigan, 49085, United States

Location

Providence Hospital Cancer Center

Southfield, Michigan, 48075, United States

Location

St. Luke's Hospital

Duluth, Minnesota, 55805, United States

Location

Washington University Barnard Cancer Center

St Louis, Missouri, 63110, United States

Location

Mercy Oncology-Hematology Limited

St Louis, Missouri, 63141, United States

Location

Cancer Resource Center - Lincoln

Lincoln, Nebraska, 68510-4844, United States

Location

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Trinitas Hospital - Jersey Street Campus

Elizabeth, New Jersey, 07201, United States

Location

Northern NJ Cancer Associates

Hackensack, New Jersey, 07601, United States

Location

Lovelace Health Systems

Albuquerque, New Mexico, 87108, United States

Location

Veterans Affairs Medical Center - Buffalo

Buffalo, New York, 14215, United States

Location

Office of Hal Gerstein

Great Neck, New York, 11022, United States

Location

Saint Vincents Comprehensive Breast Center

New York, New York, 10011, United States

Location

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

Veterans Affairs Medical Center - Northport

Northport, New York, 11768, United States

Location

University of Rochester Cancer Center

Rochester, New York, 14642, United States

Location

Office of Janak K. Choksi

Burlington, North Carolina, 27216, United States

Location

Raleigh Hematology/Oncology Associates - Wake Practice

Raleigh, North Carolina, 27609, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Hematology Oncology Consultants Inc

Columbus, Ohio, 43235, United States

Location

HillCrest Hospital

Mayfield Heights, Ohio, 44124, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213-3489, United States

Location

Cancer Centers of the Carolinas

Greenville, South Carolina, 29605, United States

Location

West Clinic, P.C.

Memphis, Tennessee, 38117, United States

Location

Memphis Cancer Center

Memphis, Tennessee, 38119, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

Medical Group of Texas

Dallas, Texas, 75243, United States

Location

Joe Arrington Cancer Center

Lubbock, Texas, 79410, United States

Location

MultiCare Hematolgy/Oncology Clinic

Tacoma, Washington, 98405, United States

Location

Lakeridge Health Oshawa

Oshawa, Ontario, L1G 2B9, Canada

Location

McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

Veterans Affairs Medical Center - San Juan

San Juan, 00927-5800, Puerto Rico

Location

University of Puerto Rico School of Medicine Medical Sciences Campus

San Juan, 00936-5067, Puerto Rico

Location

Related 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 randomized phase II trial. Am J Clin Oncol. 2007 Jun;30(3):245-51. doi: 10.1097/01.coc.0000256103.21797.e5.

  PMID: 17551300 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Vinorelbine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Tess Delacruz, RN, BSN

  GlaxoSmithKline

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 2, 2000
• First Posted: March 24, 2004
• Study Start: April 1, 2000
• Study Completion: June 1, 2007
• Last Updated: January 6, 2014

Record last verified: 2007-06

Locations

US (46); CA (2); PR (2)