Docetaxel and Vinorelbine Plus Filgrastim in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
NCT ID: NCT00006215
Last Updated: 2013-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
INTERVENTIONAL
1999-10-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus filgrastim in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
Detailed Description
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OUTLINE: This is a multicenter study. Patients receive vinorelbine IV over 6-10 minutes and docetaxel IV over 1 hour on day 1 and filgrastim (G-CSF) subcutaneously daily on days 2-12 or until blood counts recover. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 1 year.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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filgrastim
docetaxel
vinorelbine tartrate
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 70-100% Life expectancy: Greater than 2 months Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: AST and ALT no greater than 1.5 times upper limit of normal (ULN) Bilirubin no greater than ULN Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No uncontrolled hypertension, unstable angina, congestive heart failure, or atrial or ventricular arrhythmias At least 6 months since prior myocardial infarction Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No poorly controlled diabetes No known allergy to E. coli derivatives or any products to be administered No other prior malignancy within the past 5 years except surgically cured basal cell skin cancer or carcinoma in situ of the cervix No active infection or fever Not previously entered in this study
PRIOR CONCURRENT THERAPY: Biologic therapy: No other concurrent hematopoietic growth factors Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 2 weeks since prior radiotherapy and recovered Surgery: At least 2 weeks since prior major thoracic or abdominal surgery and recovered At least 6 months since prior coronary angioplasty Other: At least 30 days since prior investigational agents No other concurrent investigational agent No prophylactic acetaminophen for fever
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Principal Investigators
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Barbara Allen, DVM, MBA, PharmD
Role: STUDY_CHAIR
Amgen
Locations
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Gould Medical Group
Modesto, California, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, United States
Georgia Cancer Treatment Center, P.C.
Riverdale, Georgia, United States
Oncology and Hematology Associates
Westwood, Kansas, United States
Veterans Affairs Medical Center - Brooklyn
Brooklyn, New York, United States
Hematology-Oncology Associates of Rockland, P.C.
New City, New York, United States
New York Medical College
Valhalla, New York, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Community Oncology Group
Independence, Ohio, United States
CCOP - Dayton
Kettering, Ohio, United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, United States
Charleston Hematology-Oncology, P.A.
Charleston, South Carolina, United States
Trident Palmetto Hematology/Oncology
North Charleston, South Carolina, United States
Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group
Memphis, Tennessee, United States
Texas Cancer Care
Fort Worth, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Hematology & Oncology Associates of Virginia
Richmond, Virginia, United States
Morgantown Internal Medicine Group
Morgantown, West Virginia, United States
Countries
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Other Identifiers
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AMGEN-GCSF-990138
Identifier Type: -
Identifier Source: secondary_id
NCI-V00-1596
Identifier Type: -
Identifier Source: secondary_id
CDR0000067941
Identifier Type: -
Identifier Source: org_study_id