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Gemcitabine and Docetaxel in Treating Patients With Inoperable Stage IIIB or Stage IV Non-Small Cell Lung Cancer Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Gemcitabine and Docetaxel in Treating Patients With Inoperable Stage IIIB or Stage IV Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Gemcitabine and Docetaxel in Treating Patients With Inoperable Stage IIIB or Stage IV Non-Small Cell Lung Cancer Clinical research trials and Gemcitabine and Docetaxel in Treating Patients With Inoperable Stage IIIB or Stage IV Non-Small Cell Lung Cancer healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Gemcitabine and Docetaxel in Treating Patients With Inoperable Stage IIIB or Stage IV Non-Small Cell Lung Cancer. Gemcitabine and Docetaxel in Treating Patients With Inoperable Stage IIIB or Stage IV Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Gemcitabine and Docetaxel in Treating Patients With Inoperable Stage IIIB or Stage IV Non-Small Cell Lung Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Gemcitabine and Docetaxel in Treating Patients With Inoperable Stage IIIB or Stage IV Non-Small Cell Lung Cancer condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "G" Clinical Trials Conditions > Gemcitabine and Docetaxel in Treating Patients With Inoperable Stage IIIB or Stage IV Non-Small Cell Lung Cancer  Gemcitabine and Docetaxel in Treating Patients With Inoperable Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Gemcitabine and Docetaxel in Treating Patients With Inoperable Stage IIIB or Stage IV Non-Small Cell Lung Cancer
For Condition: squamous cell lung cancer,stage 4 non-small cell lung cancer,large cell lung cancer,stage 3B non-small cell lung cancer,adenocarcinoma of the lung
Status: Recruiting
Sponsor(s): GERCOR ,
Synopsis: RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with docetaxel in treating patients who have inoperablestage IIIB or stage IV non-small cell lung cancer.
Details: OBJECTIVES: Primary - Determine the response rate in patients with inoperable stage IIIB or IV non-small cell lung cancer treated with gemcitabine and docetaxel. Secondary - Determine the progression-free and overall survival of patients treated with this regimen. - Determine the tolerance profile of this regimen in these patients. - Determine the quality of life of patients treated with this regimen. OUTLINE: This is a nonrandomized, multicenter study. Patients receive docetaxel IV over 1 hour and gemcitabine IV over 2 hours on day 1. Treatment repeats every 15 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, after courses 6 and 12, and then every 3 months thereafter. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study within 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed non-small cell lung cancer of 1 of the following histologic subtypes: - Epidermoid carcinoma - Large cell carcinoma - Adenocarcinoma - Stage IIIB (T4, any N, M0 OR any T, N3, M0) OR Stage IV disease - Inoperable disease - Measurable disease - At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - No symptomatic brain metastases PATIENT CHARACTERISTICS: Age - 18 to 75 Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Platelet count at least 100,000/mm^3 - Absolute neutrophil count at least 2,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic - Bilirubin no greater than normal - Transaminases no greater than 1.5 times normal - Alkaline phosphatase no greater than 2.5 times normal Renal - Creatinine no greater than 2.3 mg/dL Cardiovascular - No uncontrolled cardiac insufficiency Other - Not pregnant or nursing - Fertile patients must use effective contraception during and for 6 months after study therapy - No uncontrolled infection - No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix - No grade 3 or 4 brain disorder - No intolerance to polysorbate 80 or cortisones PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy, including taxanes or gemcitabine - No other concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy to more than 20% of the bone marrow - No prior radiotherapy for lung cancer - At least 4 weeks since other prior radiotherapy and recovered Surgery - No prior surgery for lung cancer Other - More than 30 days since prior clinical trial participation
Total Enrollment:
Location and Contact Information:
Overall Study Official:
P.Terrioux, , Clinique de Docteur Terrioux
Hopital Paul Brousse *Recruiting*
Villejuif, , 94804
France
Recruiting Bouchahda 33-1-4559-3000
Polyclinique De Courlancy *Recruiting*
Reims, , F-51100
France
Recruiting Philippe Colin 33-3-2684-0284
Hopital Perpetuel Secours *Recruiting*
Levallois-Perret, , 92300
France
Recruiting Lerol 33-47-59-59-59
Hopital Tenon *Recruiting*
Paris, , 75970
France
Recruiting Karine Beerblock 33-1-5601-7000
Centre Jean Bernard *Recruiting*
Le Mans, , 72000
France
Recruiting Gerard Ganem 334-339-1300
Clinique les Bleuets *Recruiting*
Reims, , 51100
France
Recruiting Tredaniel Picavet 33-3-26-06-81-81
Centre de Radiotherapie et Oncologie Saint-Faron *Recruiting*
Mareuil-les-Meaux, , 77100
France
Recruiting Jacques Mandet 33-16-43-34-848
American Hospital of Paris *Recruiting*
Neuilly-sur-Seine, , F-92202
France
Recruiting Bertrand Callet 33-1-4641-2525
Centre Rene Huguenin *Recruiting*
Saint Cloud, , 92211
France
Recruiting E.G.C. Brain 33-147-111-515
Clinique Francois *Recruiting*
Saint-Dizier, , 52100
France
Recruiting Philippe Colin 33-3-2556-7777
Hopital Avicenne *Recruiting*
Bobigny, , 93009
France
Recruiting Jean Morere 33-1-48-955-032
Clinique de Docteur Terrioux *Recruiting*
Meaux, , 77100
France
Recruiting P. Terrioux 33-1-60-24-70-81
Additional Information:
Study ID Numbers: CDR0000346806; FRE-GERCOR-DOCEGEM-B00-2,EU-20331
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075517
Other Squamous Cell Lung Cancer Studies:
1. Cetuximab, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Unresectable Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer
2. Prognostic Study of Metastases in Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer That Can Be Removed by Surgery
3. Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer
4. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Non-small Cell Lung Cancer
5. Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
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Gemcitabine and Docetaxel in Treating Patients With Inoperable Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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