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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Lee S Schwartzberg, MD, FACP

Investigator Role:

Principal Investigator

Investigator Affiliation:

The West Clinic, PC

Authority:

United States: Food and Drug Administration

Study ID:

SD01-20010120

NCT ID:

NCT00050674

Start Date:

November 2001

Completion Date:

February 2007

Related Keywords:

  • Non-Small Cell Lung Cancer
  • lung cancer, oncology, neutropenia, chemotherapy, filgrastim
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
The West Clinic, PC Southaven, Mississippi  38671
The West Clinic, PC Memphis, Tennessee  38120