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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005865 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: vinorelbine ditartrate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| 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 Start Date: | April 2000 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Arizona Clinical Research Center | |
| Tucson, Arizona, United States, 85712 | |
| Veterans Affairs Medical Center - Tucson | |
| Tucson, Arizona, United States, 85723 | |
| United States, Arkansas | |
| Genesis Cancer Center | |
| Hot Springs, Arkansas, United States, 71913 | |
| Highlands Oncology Group, P.A. | |
| Fayetteville, Arkansas, United States, 72703 | |
| United States, California | |
| Cancer Care Consultants of Northern California | |
| Redding, California, United States, 96009-3100 | |
| NorthBay Healthcare System | |
| Fairfield, California, United States, 94533 | |
| Wilshire Oncology Medical Center | |
| Pomona, California, United States, 91767 | |
| United States, Florida | |
| Comprehensive Cancer Care Specialists of Boca Raton | |
| Boca Raton, Florida, United States, 33428 | |
| West Florida Cancer Institute - Pensacola | |
| Pensacola, Florida, United States, 32514 | |
| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| United States, Indiana | |
| South Bend Clinic and SurgiCenter | |
| South Bend, Indiana, United States, 46634 | |
| United States, Louisiana | |
| Medical Oncology, LLC | |
| Baton Rouge, Louisiana, United States, 70808 | |
| Office of Luis Alberto Meza | |
| Lafayette, Louisiana, United States, 70503 | |
| United States, Massachusetts | |
| Berkshire Physicians and Surgeons, P.C. | |
| Pittsfield, Massachusetts, United States, 01201 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| Lakeland Medical Center - St. Joseph | |
| Saint Joseph, Michigan, United States, 49085 | |
| Providence Hospital Cancer Center | |
| Southfield, Michigan, United States, 48075 | |
| Sparrow Regional Cancer Center | |
| Lansing, Michigan, United States, 48909 | |
| United States, Minnesota | |
| St. Luke's Hospital | |
| Duluth, Minnesota, United States, 55805 | |
| United States, Missouri | |
| Mercy Oncology-Hematology Limited | |
| Saint Louis, Missouri, United States, 63141 | |
| Washington University Barnard Cancer Center | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| Cancer Resource Center - Lincoln | |
| Lincoln, Nebraska, United States, 68510-4844 | |
| United States, New Hampshire | |
| Norris Cotton Cancer Center | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| United States, New Jersey | |
| Northern NJ Cancer Associates | |
| Hackensack, New Jersey, United States, 07601 | |
| Trinitas Hospital - Jersey Street Campus | |
| Elizabeth, New Jersey, United States, 07201 | |
| United States, New Mexico | |
| Lovelace Health Systems | |
| Albuquerque, New Mexico, United States, 87108 | |
| United States, New York | |
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | |
| New York, New York, United States, 10016 | |
| Office of Hal Gerstein | |
| Great Neck, New York, United States, 11022 | |
| Saint Vincents Comprehensive Breast Center | |
| New York, New York, United States, 10011 | |
| Veterans Affairs Medical Center - Northport | |
| Northport, New York, United States, 11768 | |
| Veterans Affairs Medical Center - Buffalo | |
| Buffalo, New York, United States, 14215 | |
| University of Rochester Cancer Center | |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| Office of Janak K. Choksi | |
| Burlington, North Carolina, United States, 27216 | |
| Raleigh Hematology/Oncology Associates - Wake Practice | |
| Raleigh, North Carolina, United States, 27609 | |
| United States, Ohio | |
| Hematology Oncology Consultants Inc | |
| Columbus, Ohio, United States, 43235 | |
| HillCrest Hospital | |
| Mayfield Heights, Ohio, United States, 44124 | |
| Ireland Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| United States, Pennsylvania | |
| University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15213-3489 | |
| United States, South Carolina | |
| Cancer Centers of the Carolinas | |
| Greenville, South Carolina, United States, 29605 | |
| United States, Tennessee | |
| Memphis Cancer Center | |
| Memphis, Tennessee, United States, 38119 | |
| West Clinic, P.C. | |
| Memphis, Tennessee, United States, 38117 | |
| United States, Texas | |
| Joe Arrington Cancer Center | |
| Lubbock, Texas, United States, 79410 | |
| Medical Group of Texas | |
| Dallas, Texas, United States, 75243 | |
| Simmons Cancer Center - Dallas | |
| Dallas, Texas, United States, 75235-9154 | |
| United States, Washington | |
| MultiCare Hematolgy/Oncology Clinic | |
| Tacoma, Washington, United States, 98405 | |
| Canada, Ontario | |
| Lakeridge Health Oshawa | |
| Oshawa, Ontario, Canada, L1G 2B9 | |
| Canada, Quebec | |
| McGill University | |
| Montreal, Quebec, Canada, H2W 1S6 | |
| Puerto Rico | |
| University of Puerto Rico School of Medicine Medical Sciences Campus | |
| San Juan, Puerto Rico, 00936-5067 | |
| Veterans Affairs Medical Center - San Juan | |
| San Juan, Puerto Rico, 00927-5800 | |
| Study Chair: | Tess Delacruz, RN, BSN | GlaxoSmithKline |
More Information
| Study ID Numbers: | CDR0000067897, GW-VINA2004 |
| Study First Received: | June 2, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00005865 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Vinblastine Antimitotic Agents Pharmacologic Actions Carcinoma Neoplasms |
Neoplasms by Site Vinorelbine Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Tubulin Modulators Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |