Clinical trial NCT00005865: Vinorelbine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-03-24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

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