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

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Schwartzberg, Lee, M.D.
ClinicalTrials.gov Identifier:
NCT00050674
First received: December 17, 2002
Last updated: December 26, 2012
Last verified: December 2012
History of Changes
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Docetaxel and Gemcitabine With Filgrastim-SD/01 Support in Patients With Advanced Non-Small Cell Lung Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

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

Enrollment: 40
Study Start Date: November 2001
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Filgrastim-SD/01
6 mg SC, Day 9, 24 hours after the end of the chemotherapy infusion
 Drug: Filgrastim-SD/01
6 mg SC on Day 9 (24 hours after the end of the chemotherapy infusion)

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

Locations
United States, Mississippi
The West Clinic, PC
Southaven, Mississippi, United States, 38671
United States, Tennessee
The West Clinic, PC
Memphis, Tennessee, United States, 38120
Sponsors and Collaborators
Schwartzberg, Lee, M.D.
Amgen
Investigators
Principal Investigator: Lee S Schwartzberg, MD, FACP The West Clinic, PC
  More Information

No publications provided

Responsible Party: Schwartzberg, Lee, M.D.
ClinicalTrials.gov Identifier: NCT00050674     History of Changes
Other Study ID Numbers: SD01-20010120
Study First Received: December 17, 2002
Last Updated: December 26, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Schwartzberg, Lee, M.D.:
lung cancer, oncology, neutropenia, chemotherapy, filgrastim

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Docetaxel
 Lenograstim
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on May 21, 2013