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Home > "D" Clinical Trials Conditions > Docetaxel and Vinorelbine Plus Filgrastim in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Docetaxel and Vinorelbine Plus Filgrastim in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer



Docetaxel and Vinorelbine Plus Filgrastim in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

For Condition: stage 4 non-small cell lung cancer,stage 3B non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): Amgen ,
Synopsis: 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.
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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
BarbaraAllen,  Study Chair,  Amgen

Oncology and Hematology Associates
Westwood,  Kansas,  66205
United States
 

Morgantown Internal Medicine Group
Morgantown,  West Virginia,  26505
United States
 

Trident Palmetto Hematology/Oncology
North Charleston,  South Carolina,  29406
United States
 

Gould Medical Group
Modesto,  California,  95353
United States
 

Cleveland Clinic Taussig Cancer Center
Cleveland,  Ohio,  44195
United States
 

Charleston Hematology-Oncology, P.A.
Charleston,  South Carolina,  29403
United States
 

Hematology-Oncology Associates of Rockland, P.C.
New City,  New York,  10956
United States
 

Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group
Memphis,  Tennessee,  38119
United States
 

CCOP - Dayton
Kettering,  Ohio,  45429
United States
 

CCOP - Toledo Community Hospital Oncology Program
Toledo,  Ohio,  43623-3456
United States
 

New York Medical College
Valhalla,  New York,  10595
United States
 

Community Oncology Group
Independence,  Ohio,  44131
United States
 

University of Texas Medical Branch
Galveston,  Texas,  77555-0209
United States
 

Sibley Memorial Hospital
Washington D.C.,  District of Columbia,  20016
United States
 

Hematology & Oncology Associates of Virginia
Richmond,  Virginia,  23226
United States
 

Veterans Affairs Medical Center - Washington, DC
Washington D.C.,  District of Columbia,  20422
United States
 

Georgia Cancer Treatment Center, P.C.
Riverdale,  Georgia,  30274
United States
 

Veterans Affairs Medical Center - Brooklyn
Brooklyn,  New York,  11209
United States
 

Texas Cancer Care
Ft. Worth,  Texas,  76104
United States
 


Additional Information:
Study ID Numbers:
  CDR0000067941;  AMGEN-GCSF-990138,NCI-V00-1596
Study Start Date: October 1999
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006215

Other Stage 3b Non-Small Cell Lung Cancer Studies:
1. Paclitaxel Plus Radiation Therapy in Treating Patients With Untreated Stage III Non-small Cell Lung Cancer

2. Monoclonal Antibody Plus Carboplatin and Paclitaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer

3. Fludeoxyglucose F18 Positron Emission Tomography Imaging In Assessing Patients Before and After Treatment for Locally Advanced Non-Small Cell Lung Cancer

4. Amifostine in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer

5. Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer

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