RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. 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.

Condition	Treatment or Intervention	Phase
stage IV non-small cell lung cancer stage IIIB non-small cell lung cancer	Drug: docetaxel  Drug: filgrastim  Drug: vinorelbine	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the response to docetaxel and vinorelbine with filgrastim (G-CSF) support in patients with stage IIIB or IV non-small cell lung cancer. II. Determine the toxicity of this regimen in these patients. III. Determine the overall survival and time to tumor progression in patients treated with this regimen.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically or cytologically confirmed stage IIIB or IV non-small cell lung cancer
• Bidimensionally measurable or evaluable disease
• No symptomatic brain metastases

--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

--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

California
      Gould Medical Group, Modesto,  California,  95353,  United States
District of Columbia
      Sibley Memorial Hospital, Washington,  District of Columbia,  20016,  United States
      Veterans Affairs Medical Center - Washington, DC, Washington,  District of Columbia,  20422,  United States
Georgia
      Georgia Cancer Treatment Center, P.C., Riverdale,  Georgia,  30274,  United States
Kansas
      Oncology and Hematology Associates, Westwood,  Kansas,  66205,  United States
New York
      Hematology-Oncology Associates of Rockland, P.C., New City,  New York,  10956,  United States
      New York Medical College, Valhalla,  New York,  10595,  United States
      Veterans Affairs Medical Center - Brooklyn, Brooklyn,  New York,  11209,  United States
Ohio
      CCOP - Dayton, Kettering,  Ohio,  45429,  United States
      CCOP - Toledo Community Hospital Oncology Program, Toledo,  Ohio,  43623-3456,  United States
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States
      Community Oncology Group, Independence,  Ohio,  44131,  United States
South Carolina
      Charleston Hematology-Oncology, P.A., Charleston,  South Carolina,  29403,  United States
      Trident Palmetto Hematology/Oncology, North Charleston,  South Carolina,  29406,  United States
Tennessee
      Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group, Memphis,  Tennessee,  38119,  United States
Texas
      Texas Cancer Care, Fort Worth,  Texas,  76104,  United States
      University of Texas Medical Branch, Galveston,  Texas,  77555-0209,  United States
Virginia
      Hematology & Oncology Associates of Virginia, Richmond,  Virginia,  23226,  United States
West Virginia
      Morgantown Internal Medicine Group, Morgantown,  West Virginia,  26505,  United States

Study chairs or principal investigators

Barbara Allen,  Study Chair,  Amgen   

Study ID Numbers:  CDR0000067941; AMGEN-GCSF-990138; NCI-V00-1596
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  September 11, 2000
ClinicalTrials.gov Identifier:  NCT00006215
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08