Trial | NCT00050674  Report issue

Official Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    40
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.
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.
Study Started
Nov 30
2001
Primary Completion
Feb 28
2007
Study Completion
Feb 28
2007
Last Update
Dec 27
2012
Estimate

Drug Filgrastim-SD/01

6 mg SC on Day 9 (24 hours after the end of the chemotherapy infusion)

Filgrastim-SD/01 Experimental

6 mg SC, Day 9, 24 hours after the end of the chemotherapy infusion

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
No Results Posted