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

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
filgrastim
docetaxel
vinorelbine tartrate
Sponsored by
Amgen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gould Medical Group
  • Sibley Memorial Hospital
  • Veterans Affairs Medical Center - Washington, DC
  • Georgia Cancer Treatment Center, P.C.
  • Oncology and Hematology Associates
  • Veterans Affairs Medical Center - Brooklyn
  • Hematology-Oncology Associates of Rockland, P.C.
  • New York Medical College
  • Cleveland Clinic Taussig Cancer Center
  • Community Oncology Group
  • CCOP - Dayton
  • CCOP - Toledo Community Hospital Oncology Program
  • Charleston Hematology-Oncology, P.A.
  • Trident Palmetto Hematology/Oncology
  • Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group
  • Texas Cancer Care
  • University of Texas Medical Branch
  • Hematology & Oncology Associates of Virginia
  • Morgantown Internal Medicine Group

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 11, 2000
Last Updated
December 18, 2013
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT00006215
Brief Title
Docetaxel and Vinorelbine Plus Filgrastim in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Official Title
A Phase II Study of Docetaxel and Vinorelbine in Advanced Non-Small Cell Lung Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2001
Overall Recruitment Status
Unknown status
Study Start Date
October 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Amgen

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
vinorelbine tartrate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Allen, DVM, MBA, PharmD
Organizational Affiliation
Amgen
Official's Role
Study Chair
Facility Information:
Facility Name
Gould Medical Group
City
Modesto
State/Province
California
ZIP/Postal Code
95353
Country
United States
Facility Name
Sibley Memorial Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Veterans Affairs Medical Center - Washington, DC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Georgia Cancer Treatment Center, P.C.
City
Riverdale
State/Province
Georgia
ZIP/Postal Code
30274
Country
United States
Facility Name
Oncology and Hematology Associates
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Veterans Affairs Medical Center - Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11209
Country
United States
Facility Name
Hematology-Oncology Associates of Rockland, P.C.
City
New City
State/Province
New York
ZIP/Postal Code
10956
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Community Oncology Group
City
Independence
State/Province
Ohio
ZIP/Postal Code
44131
Country
United States
Facility Name
CCOP - Dayton
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
CCOP - Toledo Community Hospital Oncology Program
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623-3456
Country
United States
Facility Name
Charleston Hematology-Oncology, P.A.
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
Trident Palmetto Hematology/Oncology
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Texas Cancer Care
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0209
Country
United States
Facility Name
Hematology & Oncology Associates of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Morgantown Internal Medicine Group
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States

12. IPD Sharing Statement

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

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