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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00050674
• Other study ID #: SD01-20010120
• Status: Completed
• Phase: Phase 2
• First received: December 17, 2002
• Last updated: December 26, 2012
• Start date: November 2001
• Est. completion date: February 2007

Study information

• Verified date: December 2012
• Source: Schwartzberg, Lee, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• 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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Filgrastim-SD/01
6 mg SC on Day 9 (24 hours after the end of the chemotherapy infusion)

Locations

Country	Name	City	State
United States	The West Clinic, PC	Memphis	Tennessee
United States	The West Clinic, PC	Southaven	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
Schwartzberg, Lee, M.D.	Amgen

Country where clinical trial is conducted

United States, 

External Links

•   Link