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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Tess Delacruz, RN, BSN

Investigator Role:

Study Chair

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Federal Government

Study ID:

CDR0000067897

NCT ID:

NCT00005865

Start Date:

April 2000

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Rochester Cancer CenterRochester, New York  14642
Ireland Cancer CenterCleveland, Ohio  44106-5065
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
West Florida Cancer Institute - PensacolaPensacola, Florida  32514
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
Medical Group of TexasDallas, Texas  75243
Trinitas Hospital - Jersey Street CampusElizabeth, New Jersey  07201
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Lakeland Medical Center - St. JosephSaint Joseph, Michigan  49085
Hematology Oncology Consultants IncColumbus, Ohio  43235
Washington University Barnard Cancer CenterSaint Louis, Missouri  63110
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Providence Hospital Cancer CenterSouthfield, Michigan  48075
Highlands Oncology Group, P.A.Fayetteville, Arkansas  72703
Cancer Resource Center - LincolnLincoln, Nebraska  68510
Wilshire Oncology Medical CenterPomona, California  91767
St. Luke's HospitalDuluth, Minnesota  55805-2193
Arizona Clinical Research CenterTucson, Arizona  85712
Berkshire Physicians and Surgeons, P.C.Pittsfield, Massachusetts  01201
Joe Arrington Cancer CenterLubbock, Texas  79410
West Clinic, P.C.Memphis, Tennessee  38117
Comprehensive Cancer Care Specialists of Boca RatonBoca Raton, Florida  33428
Raleigh Hematology/Oncology Associates - Wake PracticeRaleigh, North Carolina  27609
Genesis Cancer CenterHot Springs, Arkansas  71913
NorthBay Healthcare SystemFairfield, California  94533
Cancer Care Consultants of Northern CaliforniaRedding, California  96009-3100
South Bend Clinic and SurgiCenterSouth Bend, Indiana  46634
Medical Oncology, LLCBaton Rouge, Louisiana  70808
Office of Luis Alberto MezaLafayette, Louisiana  70503
Mercy Oncology-Hematology LimitedSaint Louis, Missouri  63141
Northern NJ Cancer AssociatesHackensack, New Jersey  07601
Lovelace Health SystemsAlbuquerque, New Mexico  87108
Office of Hal GersteinGreat Neck, New York  11022
Saint Vincents Comprehensive Breast CenterNew York, New York  10011
Veterans Affairs Medical Center - NorthportNorthport, New York  11768
Office of Janak K. ChoksiBurlington, North Carolina  27216
HillCrest HospitalMayfield Heights, Ohio  44124
Memphis Cancer CenterMemphis, Tennessee  38119
MultiCare Hematolgy/Oncology ClinicTacoma, Washington  98405