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

NCT ID: NCT00050674

Last Updated: 2012-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2007-02-28

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.

Conditions

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Non-small Cell Lung Cancer

Keywords

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lung cancer, oncology, neutropenia, chemotherapy, filgrastim

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Filgrastim-SD/01

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

Group Type EXPERIMENTAL

Filgrastim-SD/01

Intervention Type DRUG

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

Interventions

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Filgrastim-SD/01

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role collaborator

Schwartzberg, Lee, M.D.

INDIV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lee S Schwartzberg, MD, FACP

Role: PRINCIPAL_INVESTIGATOR

The West Clinic, PC

Locations

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The West Clinic, PC

Southaven, Mississippi, United States

Site Status

The West Clinic, PC

Memphis, Tennessee, United States

Site Status

Countries

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United States

Related Links

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http://westclinic.com

Related Info

Other Identifiers

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SD01-20010120

Identifier Type: -

Identifier Source: org_study_id