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

This study is currently recruiting participants.

Verified by Schwartzberg, Lee, M.D., December 2002

First Received: December 17, 2002 Last Updated: June 23, 2005 History of Changes

Sponsor:	Schwartzberg, Lee, M.D.
Information provided by:	Schwartzberg, Lee, M.D.
ClinicalTrials.gov Identifier:	NCT00050674

Purpose

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.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: Filgrastim-SD/01	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Control: Uncontrolled Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Filgrastim Lenograstim Granulocyte colony-stimulating factor

U.S. FDA Resources

Further study details as provided by Schwartzberg, Lee, M.D.:

Estimated Enrollment:	30
Study Start Date:	November 2001

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00050674

Contacts

Contact: Jeri L Ashley, MSN AOCN CCRC

901-683-0055

research@westclinic.com

Locations

United States, Mississippi
The West Clinic, PC	Recruiting
Southaven, Mississippi, United States, 38671
Contact: Jeri L Ashley, MSN AOCN CCRC 901-683-0055
Principal Investigator: Lee S Schwartzberg, MD, FACP
United States, Tennessee
The West Clinic, PC	Recruiting
Memphis, Tennessee, United States, 38120
Contact: Jeri L Ashley, MSN AOCN CCRC 901-683-0055
Principal Investigator: Lee S Schwartzberg, MD, FACP

Sponsors and Collaborators

Schwartzberg, Lee, M.D.

Investigators

Principal Investigator:

Lee S Schwartzberg, MD, FACP

The West Clinic, PC

More Information

No publications provided

Study ID Numbers:	SD01-20010120
Study First Received:	December 17, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00050674 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Schwartzberg, Lee, M.D.:

lung cancer, oncology, neutropenia, chemotherapy, filgrastim

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Lenograstim
Physiological Effects of Drugs
Adjuvants, Immunologic
Pharmacologic Actions

Carcinoma
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on March 18, 2010