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Docetaxel and Gemcitabine with Filgrastim-SD/01 Support in Patients with Advanced Non-Small Cell Lung Carcinoma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Docetaxel and Gemcitabine with Filgrastim-SD/01 Support in Patients with Advanced Non-Small Cell Lung Carcinoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Docetaxel and Gemcitabine with Filgrastim-SD/01 Support in Patients with Advanced Non-Small Cell Lung Carcinoma Clinical research trials and Docetaxel and Gemcitabine with Filgrastim-SD/01 Support in Patients with Advanced Non-Small Cell Lung Carcinoma health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Docetaxel and Gemcitabine with Filgrastim-SD/01 Support in Patients with Advanced Non-Small Cell Lung Carcinoma. Docetaxel and Gemcitabine with Filgrastim-SD/01 Support in Patients with Advanced Non-Small Cell Lung Carcinoma Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Docetaxel and Gemcitabine with Filgrastim-SD/01 Support in Patients with Advanced Non-Small Cell Lung Carcinoma clinical trial. Test subjects typically receive the most expert healthcare available for their Docetaxel and Gemcitabine with Filgrastim-SD/01 Support in Patients with Advanced Non-Small Cell Lung Carcinoma condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Docetaxel and Gemcitabine with Filgrastim-SD/01 Support in Patients with Advanced Non-Small Cell Lung Carcinoma  Docetaxel and Gemcitabine with Filgrastim-SD/01 Support in Patients with Advanced Non-Small Cell Lung Carcinoma
Docetaxel and Gemcitabine with Filgrastim-SD/01 Support in Patients with Advanced Non-Small Cell Lung Carcinoma
For Condition: Non-small cell lung cancer
Status: Recruiting
Sponsor(s): Schwartzberg, Lee, M.D. ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 30
Location and Contact Information:
Overall Study Official:
LeeSchwartzberg, Principal Investigator, The West Clinic, PC
The West Clinic, PC *Recruiting*
Memphis, Tennessee, 38120
United States
Recruiting Jeri Ashley 901-683-0055
The West Clinic, PC *Recruiting*
Southaven, Mississippi, 38671
United States
Recruiting Jeri Ashley 901-683-0055
Additional Information:
Study ID Numbers: SD01-20010120;
Study Start Date: November 2001
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00050674
Other Non-Small Cell Lung Cancer Studies:
1. Isotretinoin With or Without Vitamin E for Prevention of Lung Cancer
2. Chest X-ray or Chest CT Scan in Patients at High Risk of Developing Lung Cancer
3. Captopril in Treating Patients With Non-Small Cell Lung Cancer or Limited-Stage Small Cell Lung Cancer That Has Been Previously Treated With Radiation Therapy With or Without Chemotherapy
4. ZD6474 and Docetaxel in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
5. KRN7000 in Treating Patients With Solid Tumors
Related Studies:
Other Non-small cell lung cancer Clinical Trials
Other Tennessee Clinical Trials
Other Memphis Clinical Trials
Docetaxel and Gemcitabine with Filgrastim-SD/01 Support in Patients with Advanced Non-Small Cell Lung Carcinoma
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