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Gemcitabine and Docetaxel in Treating Patients With Inoperable Stage IIIB or Stage IV Non-Small Cell Lung Cancer Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD 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 medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like 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 for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again 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. Subjects typically recieve the finest healthcare available for their Gemcitabine and Docetaxel in Treating Patients With Inoperable Stage IIIB or Stage IV Non-Small Cell Lung Cancer condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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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 Stage 3b Non-Small Cell Lung Cancer Studies:
1. Gefitinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
2. A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Phase III Study of Tariquidar + Vinorelbine as First-Line Therapy in Non-Small Cell Lung Cancer (NSCLC)
3. Paclitaxel and Carboplatin With or Without BMS-275291 in Treating Patients With Advanced or Metastatic Non-small Cell Lung Cancer
4. Antineoplaston Therapy in Treating Patients With Recurrent or Stage IV Lung Cancer
5. Combination Chemotherapy With or Without Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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Other stage 3B non-small cell lung cancer Clinical Trials
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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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