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

Lung Cancer Clinical Trial

Official title:

A Phase II Study of Docetaxel and Vinorelbine in Advanced Non-Small Cell Lung Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00006215
• Other study ID #: CDR0000067941
• Secondary ID: AMGEN-GCSF-99013
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 11, 2000
• Last updated: December 18, 2013
• Start date: October 1999

Study information

• Verified date: December 2001
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Biological:
• filgrastim

Drug:
• docetaxel

• vinorelbine tartrate

Locations

Country	Name	City	State
United States	Veterans Affairs Medical Center - Brooklyn	Brooklyn	New York
United States	Charleston Hematology-Oncology, P.A.	Charleston	South Carolina
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Texas Cancer Care	Fort Worth	Texas
United States	University of Texas Medical Branch	Galveston	Texas
United States	Community Oncology Group	Independence	Ohio
United States	CCOP - Dayton	Kettering	Ohio
United States	Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group	Memphis	Tennessee
United States	Gould Medical Group	Modesto	California
United States	Morgantown Internal Medicine Group	Morgantown	West Virginia
United States	Hematology-Oncology Associates of Rockland, P.C.	New City	New York
United States	Trident Palmetto Hematology/Oncology	North Charleston	South Carolina
United States	Hematology & Oncology Associates of Virginia	Richmond	Virginia
United States	Georgia Cancer Treatment Center, P.C.	Riverdale	Georgia
United States	CCOP - Toledo Community Hospital Oncology Program	Toledo	Ohio
United States	New York Medical College	Valhalla	New York
United States	Sibley Memorial Hospital	Washington	District of Columbia
United States	Veterans Affairs Medical Center - Washington, DC	Washington	District of Columbia
United States	Oncology and Hematology Associates	Westwood	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States,