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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Filgrastim-SD/01


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Filgrastim-SD/01<br>6 mg SC, Day 9, 24 hours after the end of the chemotherapy infusion | Drug: Filgrastim-SD/01<br>* 6 mg SC on Day 9 (24 hours after the end of the chemotherapy infusion)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer, oncology, neutropenia, chemotherapy, filgrastim