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Sponsored by: |
Schwartzberg, Lee, M.D. |
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Information provided by: | Schwartzberg, Lee, M.D. |
ClinicalTrials.gov Identifier: | NCT00050674 |
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.
Condition | Intervention | Phase |
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Non-Small Cell Lung Cancer |
Drug: Filgrastim-SD/01 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 30 |
Study Start Date: | November 2001 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Contact: Jeri L Ashley, MSN AOCN CCRC | 901-683-0055 | research@westclinic.com |
United States, Mississippi | |
The West Clinic, PC | Recruiting |
Southaven, Mississippi, United States, 38671 | |
Contact: Jeri L Ashley, MSN AOCN CCRC 901-683-0055 | |
Principal Investigator: Lee S Schwartzberg, MD, FACP | |
United States, Tennessee | |
The West Clinic, PC | Recruiting |
Memphis, Tennessee, United States, 38120 | |
Contact: Jeri L Ashley, MSN AOCN CCRC 901-683-0055 | |
Principal Investigator: Lee S Schwartzberg, MD, FACP |
Principal Investigator: | Lee S Schwartzberg, MD, FACP | The West Clinic, PC |
Study ID Numbers: | SD01-20010120 |
Study First Received: | December 17, 2002 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00050674 |
Health Authority: | United States: Food and Drug Administration |
lung cancer, oncology, neutropenia, chemotherapy, filgrastim |
Docetaxel Thoracic Neoplasms Neutropenia Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Gemcitabine Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |