Clinical trial NCT00006215: Docetaxel and Vinorelbine Plus Filgrastim in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Official title: A Phase II Study of Docetaxel and Vinorelbine in Advanced Non-Small Cell Lung Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lung Cancer
Keywords: stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-03-17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

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.

Eligibility 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

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Modesto
country: United States
facility: Gould Medical Group
state: California
city: Washington
country: United States
facility: Sibley Memorial Hospital
state: District of Columbia
city: Washington
country: United States
facility: Veterans Affairs Medical Center - Washington, DC
state: District of Columbia
city: Riverdale
country: United States
facility: Georgia Cancer Treatment Center, P.C.
state: Georgia
city: Westwood
country: United States
facility: Oncology and Hematology Associates
state: Kansas
city: Brooklyn
country: United States
facility: Veterans Affairs Medical Center - Brooklyn
state: New York
city: New City
country: United States
facility: Hematology-Oncology Associates of Rockland, P.C.
state: New York
city: Valhalla
country: United States
facility: New York Medical College
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
city: Independence
country: United States
facility: Community Oncology Group
state: Ohio
city: Kettering
country: United States
facility: CCOP - Dayton
state: Ohio
city: Toledo
country: United States
facility: CCOP - Toledo Community Hospital Oncology Program
state: Ohio
city: Charleston
country: United States
facility: Charleston Hematology-Oncology, P.A.
state: South Carolina
city: North Charleston
country: United States
facility: Trident Palmetto Hematology/Oncology
state: South Carolina
city: Memphis
country: United States
facility: Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group
state: Tennessee
city: Fort Worth
country: United States
facility: Texas Cancer Care
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Richmond
country: United States
facility: Hematology & Oncology Associates of Virginia
state: Virginia
city: Morgantown
country: United States
facility: Morgantown Internal Medicine Group
state: West Virginia
Study officials:
affiliation: Amgen
name: Barbara Allen, DVM, MBA, PharmD
role: STUDY_CHAIR
References: