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Docetaxel and Gemcitabine With Filgrastim-SD/01 Support in Patients With Advanced Non-Small Cell Lung Carcinoma

Primary Purpose

Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Filgrastim-SD/01
Sponsored by
Schwartzberg, Lee, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring lung cancer, oncology, neutropenia, chemotherapy, filgrastim

Eligibility Criteria

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

Histologically or cytologically documented non-small cell lung cancer Subjects must have stage IV or IIIB NSCLC 0-1 prior treatment regimens of chemotherapy Subjects must have bi-dimensionally measurable disease or evaluable disease by physical exam or radiological studies Age > 18 years 1st Line - ECOG 0-2 2nd Line - ECOG 0-1 Absolute neutrophil count > or = 1.5 x 10 to the 9th power/L Platelet count > or = 100 x 10 to the 9th power/L Adequate renal function with screening serum creatinine < or = 2.0 mg/dL Adequate AST and ALT no more than 1.5 x the upper limit of normal and serum bilirubin < or = upper limit of normal Subjects must be at least two weeks from prior major thoracic or abdominal surgery and at least two weeks from completion of radiation therapy, and recovered from all toxicities associated with these treatments Negative HCG by urine or blood test in subject of child-bearing potential Life expectancy > 2 months Ethical - Before any study specific procedure is done or before study medication is administered, the subject or legally acceptable representative must give informed consent for participation in the study

Sites / Locations

  • The West Clinic, PC
  • The West Clinic, PC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Filgrastim-SD/01

Arm Description

6 mg SC, Day 9, 24 hours after the end of the chemotherapy infusion

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 17, 2002
Last Updated
December 26, 2012
Sponsor
Schwartzberg, Lee, M.D.
Collaborators
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT00050674
Brief Title
Docetaxel and Gemcitabine With Filgrastim-SD/01 Support in Patients With Advanced Non-Small Cell Lung Carcinoma
Official Title
Docetaxel and Gemcitabine With Filgrastim-SD/01 Support in Patients With Advanced Non-Small Cell Lung Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Schwartzberg, Lee, M.D.
Collaborators
Amgen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Determine whether patients have a decreased incidence of grade 3 and grade 4 neutropenia when Filgrastim-SD/01 is given with docetaxel and gemcitabine in patients with advanced non-small cell lung cancer.
Detailed Description
Docetaxel and Gemcitabine given on day 1 and 8 of a 21-day schedule has substantial activity in non-small cell lung cancer. Both first and second-line patients have response rates comparable to or better than other standard combination regimens. Grade 3/4 neutropenia occurs in up to half of patients not given growth factor support. Studies demonstrate that a single dose of Filgrastim-SF/01 at 100 mg/kg effectively enhances post chemotherapy neutrophil recovery in a manner similar to that of daily Filgrastim. This current study is designed to characterize the incidence of grade 3/4 neutropenia when a fixed dose of Filgrastim-SD/01 is added to a well-studied myelosuppressive chemotherapy regimen consisting of Gemcitabine and Docetaxel.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
lung cancer, oncology, neutropenia, chemotherapy, filgrastim

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Filgrastim-SD/01
Arm Type
Experimental
Arm Description
6 mg SC, Day 9, 24 hours after the end of the chemotherapy infusion
Intervention Type
Drug
Intervention Name(s)
Filgrastim-SD/01
Intervention Description
6 mg SC on Day 9 (24 hours after the end of the chemotherapy infusion)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Histologically or cytologically documented non-small cell lung cancer Subjects must have stage IV or IIIB NSCLC 0-1 prior treatment regimens of chemotherapy Subjects must have bi-dimensionally measurable disease or evaluable disease by physical exam or radiological studies Age > 18 years 1st Line - ECOG 0-2 2nd Line - ECOG 0-1 Absolute neutrophil count > or = 1.5 x 10 to the 9th power/L Platelet count > or = 100 x 10 to the 9th power/L Adequate renal function with screening serum creatinine < or = 2.0 mg/dL Adequate AST and ALT no more than 1.5 x the upper limit of normal and serum bilirubin < or = upper limit of normal Subjects must be at least two weeks from prior major thoracic or abdominal surgery and at least two weeks from completion of radiation therapy, and recovered from all toxicities associated with these treatments Negative HCG by urine or blood test in subject of child-bearing potential Life expectancy > 2 months Ethical - Before any study specific procedure is done or before study medication is administered, the subject or legally acceptable representative must give informed consent for participation in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee S Schwartzberg, MD, FACP
Organizational Affiliation
The West Clinic, PC
Official's Role
Principal Investigator
Facility Information:
Facility Name
The West Clinic, PC
City
Southaven
State/Province
Mississippi
ZIP/Postal Code
38671
Country
United States
Facility Name
The West Clinic, PC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States

12. IPD Sharing Statement

Links:
URL
http://westclinic.com
Description
Related Info

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Docetaxel and Gemcitabine With Filgrastim-SD/01 Support in Patients With Advanced Non-Small Cell Lung Carcinoma

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