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

December 18, 2013 updated by: Amgen

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Modesto, California, United States, 95353
        • Gould Medical Group
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • Veterans Affairs Medical Center - Washington, DC
      • Washington, District of Columbia, United States, 20016
        • Sibley Memorial Hospital
    • Georgia
      • Riverdale, Georgia, United States, 30274
        • Georgia Cancer Treatment Center, P.C.
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Oncology and Hematology Associates
    • New York
      • Brooklyn, New York, United States, 11209
        • Veterans Affairs Medical Center - Brooklyn
      • New City, New York, United States, 10956
        • Hematology-Oncology Associates of Rockland, P.C.
      • Valhalla, New York, United States, 10595
        • New York Medical College
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Independence, Ohio, United States, 44131
        • Community Oncology Group
      • Kettering, Ohio, United States, 45429
        • CCOP - Dayton
      • Toledo, Ohio, United States, 43623-3456
        • CCOP - Toledo Community Hospital Oncology Program
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Charleston Hematology-Oncology, P.A.
      • North Charleston, South Carolina, United States, 29406
        • Trident Palmetto Hematology/Oncology
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Texas Cancer Care
      • Galveston, Texas, United States, 77555-0209
        • University of Texas Medical Branch
    • Virginia
      • Richmond, Virginia, United States, 23226
        • Hematology & Oncology Associates of Virginia
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Morgantown Internal Medicine Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Investigators

  • Study Chair: Barbara Allen, DVM, MBA, PharmD, Amgen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1999

Study Registration Dates

First Submitted

September 11, 2000

First Submitted That Met QC Criteria

March 16, 2004

First Posted (Estimate)

March 17, 2004

Study Record Updates

Last Update Posted (Estimate)

December 19, 2013

Last Update Submitted That Met QC Criteria

December 18, 2013

Last Verified

December 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067941
  • AMGEN-GCSF-990138
  • NCI-V00-1596

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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