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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00050674
Recruitment Status : Completed
First Posted : December 18, 2002
Last Update Posted : December 27, 2012
Information provided by (Responsible Party):
Schwartzberg, Lee, M.D.

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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Filgrastim-SD/01 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Docetaxel and Gemcitabine With Filgrastim-SD/01 Support in Patients With Advanced Non-Small Cell Lung Carcinoma
Study Start Date : November 2001
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Arm Intervention/treatment
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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00050674

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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.
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Principal Investigator: Lee S Schwartzberg, MD, FACP The West Clinic, PC
Additional Information:
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Responsible Party: Schwartzberg, Lee, M.D. Identifier: NCT00050674    
Other Study ID Numbers: SD01-20010120
First Posted: December 18, 2002    Key Record Dates
Last Update Posted: December 27, 2012
Last Verified: December 2012
Keywords provided by Schwartzberg, Lee, M.D.:
lung cancer, oncology, neutropenia, chemotherapy, filgrastim
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs