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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
Open (Enrolling)
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:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Tess Delacruz, RN, BSN

Investigator Role:

Study Chair

Investigator Affiliation:



United States: Federal Government

Study ID:




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



University of Chicago Cancer Research Center Chicago, Illinois  60637
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Rochester Cancer Center Rochester, New York  14642
Ireland Cancer Center Cleveland, Ohio  44106-5065
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
Norris Cotton Cancer Center Lebanon, New Hampshire  03756
University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016
West Florida Cancer Institute - Pensacola Pensacola, Florida  32514
Veterans Affairs Medical Center - Tucson Tucson, Arizona  85723
Medical Group of Texas Dallas, Texas  75243
Trinitas Hospital - Jersey Street Campus Elizabeth, New Jersey  07201
Veterans Affairs Medical Center - Buffalo Buffalo, New York  14215
Lakeland Medical Center - St. Joseph Saint Joseph, Michigan  49085
Hematology Oncology Consultants Inc Columbus, Ohio  43235
Washington University Barnard Cancer Center Saint Louis, Missouri  63110
Cancer Centers of the Carolinas Greenville, South Carolina  29605
Providence Hospital Cancer Center Southfield, Michigan  48075
Highlands Oncology Group, P.A. Fayetteville, Arkansas  72703
Cancer Resource Center - Lincoln Lincoln, Nebraska  68510
Wilshire Oncology Medical Center Pomona, California  91767
St. Luke's Hospital Duluth, Minnesota  55805-2193
Arizona Clinical Research Center Tucson, Arizona  85712
Berkshire Physicians and Surgeons, P.C. Pittsfield, Massachusetts  01201
Joe Arrington Cancer Center Lubbock, Texas  79410
West Clinic, P.C. Memphis, Tennessee  38117
Comprehensive Cancer Care Specialists of Boca Raton Boca Raton, Florida  33428
Raleigh Hematology/Oncology Associates - Wake Practice Raleigh, North Carolina  27609
Genesis Cancer Center Hot Springs, Arkansas  71913
NorthBay Healthcare System Fairfield, California  94533
Cancer Care Consultants of Northern California Redding, California  96009-3100
South Bend Clinic and SurgiCenter South Bend, Indiana  46634
Medical Oncology, LLC Baton Rouge, Louisiana  70808
Office of Luis Alberto Meza Lafayette, Louisiana  70503
Mercy Oncology-Hematology Limited Saint Louis, Missouri  63141
Northern NJ Cancer Associates Hackensack, New Jersey  07601
Lovelace Health Systems Albuquerque, New Mexico  87108
Office of Hal Gerstein Great Neck, New York  11022
Saint Vincents Comprehensive Breast Center New York, New York  10011
Veterans Affairs Medical Center - Northport Northport, New York  11768
Office of Janak K. Choksi Burlington, North Carolina  27216
HillCrest Hospital Mayfield Heights, Ohio  44124
Memphis Cancer Center Memphis, Tennessee  38119
MultiCare Hematolgy/Oncology Clinic Tacoma, Washington  98405