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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Barbara Allen, DVM, MBA, PharmD

Investigator Role:

Study Chair

Investigator Affiliation:

Amgen

Authority:

United States: Federal Government

Study ID:

CDR0000067941

NCT ID:

NCT00006215

Start Date:

October 1999

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
New York Medical CollegeValhalla, New York  10595
CCOP - DaytonKettering, Ohio  45429
University of Texas Medical BranchGalveston, Texas  77555-1329
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Veterans Affairs Medical Center - Washington, DCWashington, District of Columbia  20422
Veterans Affairs Medical Center - BrooklynBrooklyn, New York  11209
Sibley Memorial HospitalWashington, District of Columbia  20016
Oncology and Hematology AssociatesWestwood, Kansas  66205
Texas Cancer CareFort Worth, Texas  76104
Hematology & Oncology Associates of VirginiaRichmond, Virginia  23226
Boston Baskin Cancer Group, University Tennessee Oncology/Hematology GroupMemphis, Tennessee  38119
Gould Medical GroupModesto, California  95353
Georgia Cancer Treatment Center, P.C.Riverdale, Georgia  30274
Hematology-Oncology Associates of Rockland, P.C.New City, New York  10956
Community Oncology GroupIndependence, Ohio  44131
Charleston Hematology-Oncology, P.A.Charleston, South Carolina  29403
Trident Palmetto Hematology/OncologyNorth Charleston, South Carolina  29406
Morgantown Internal Medicine GroupMorgantown, West Virginia  26505