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

NCT00006215 | Unknown Phase 2

• 3 other identifiers: CDR0000067941AMGEN-GCSF-990138NCI-V00-1596
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 19

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.

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Interventions

filgrastim BIOLOGICAL

docetaxel DRUG

vinorelbine tartrate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Amgen: lead

Study Sites (19)

Gould Medical Group

Modesto, California, 95353, United States

Location

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

Location

Veterans Affairs Medical Center - Washington, DC

Washington D.C., District of Columbia, 20422, United States

Location

Georgia Cancer Treatment Center, P.C.

Riverdale, Georgia, 30274, United States

Location

Oncology and Hematology Associates

Westwood, Kansas, 66205, United States

Location

Veterans Affairs Medical Center - Brooklyn

Brooklyn, New York, 11209, United States

Location

Hematology-Oncology Associates of Rockland, P.C.

New City, New York, 10956, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Community Oncology Group

Independence, Ohio, 44131, United States

Location

CCOP - Dayton

Kettering, Ohio, 45429, United States

Location

CCOP - Toledo Community Hospital Oncology Program

Toledo, Ohio, 43623-3456, United States

Location

Charleston Hematology-Oncology, P.A.

Charleston, South Carolina, 29403, United States

Location

Trident Palmetto Hematology/Oncology

North Charleston, South Carolina, 29406, United States

Location

Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group

Memphis, Tennessee, 38119, United States

Location

Texas Cancer Care

Fort Worth, Texas, 76104, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0209, United States

Location

Hematology & Oncology Associates of Virginia

Richmond, Virginia, 23226, United States

Location

Morgantown Internal Medicine Group

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Filgrastim; Docetaxel; Vinorelbine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Barbara Allen, DVM, MBA, PharmD

  Amgen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 11, 2000
• First Posted: March 17, 2004
• Study Start: October 1, 1999
• Last Updated: December 19, 2013

Record last verified: 2001-12

Locations

US (19)