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Docetaxel and Cisplatin in Treating Patients With Untreated Stage IIIA Non-small Cell Lung Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Docetaxel and Cisplatin in Treating Patients With Untreated Stage IIIA Non-small Cell Lung Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Docetaxel and Cisplatin in Treating Patients With Untreated Stage IIIA Non-small Cell Lung Cancer Clinical research trials and Docetaxel and Cisplatin in Treating Patients With Untreated Stage IIIA Non-small Cell Lung Cancer health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Docetaxel and Cisplatin in Treating Patients With Untreated Stage IIIA Non-small Cell Lung Cancer. Docetaxel and Cisplatin in Treating Patients With Untreated Stage IIIA Non-small Cell Lung Cancer Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Docetaxel and Cisplatin in Treating Patients With Untreated Stage IIIA Non-small Cell Lung Cancer clinical trial. Participants oftentimes recieve the most expert healthcare available for their Docetaxel and Cisplatin in Treating Patients With Untreated Stage IIIA Non-small Cell Lung Cancer condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Docetaxel and Cisplatin in Treating Patients With Untreated Stage IIIA Non-small Cell Lung Cancer  Docetaxel and Cisplatin in Treating Patients With Untreated Stage IIIA Non-small Cell Lung Cancer
Docetaxel and Cisplatin in Treating Patients With Untreated Stage IIIA Non-small Cell Lung Cancer
For Condition: stage 3A non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): EORTC Lung Cancer Cooperative Group ,
Synopsis: RATIONALE: Drugs used in chemotherapy 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 docetaxel and cisplatin in treating patients who have untreated stage IIIA non-small cell lung cancer.
Details: OBJECTIVES: I. Assess the therapeutic activity of docetaxel and cisplatin in patients with untreated stage IIIA non-small cell lung cancer. II. Determine the safety of this regimen in these patients. PROTOCOL OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour on day 1 and cisplatin IV over 30 minutes on days 1 and 2. Treatment continues every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients are followed for survival. PROJECTED ACCRUAL: A total of 24-40 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 19 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically or cytologically confirmed stage IIIA non-small cell lung cancer (NSCLC) (T1-3, N2, M0) - Unresectable metastasis to ipsilateral mediastinal and/or subcarinal lymph nodes Measurable disease - Must be at least 20 mm in one dimension by conventional techniques or at least 10 mm by spiral CT scan No distant metastases No CNS involvement No pleural or pericardial effusion --Prior/Concurrent Therapy-- Biologic therapy: No concurrent immunotherapy Chemotherapy: - No prior chemotherapy for NSCLC - No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: - No prior radiotherapy for NSCLC - No concurrent radiotherapy Surgery: No prior surgery for NSCLC Other: - At least 1 month since prior investigational agents - No other concurrent experimental medications --Patient Characteristics-- Age: Over 18 Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin no greater than upper limit of normal (ULN) - AST/ALT no greater than 1.5 times ULN - Alkaline phosphatase no greater than 2.5 times ULN Renal: - Creatinine no greater than 1.25 ULN - Creatinine clearance at least 60 mL/min Cardiovascular: - No superior vena cava syndrome - No uncontrolled congestive heart failure or angina - No myocardial infarction within past year - No uncontrolled hypertension or arrhythmia Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No concurrent active infection requiring IV antibiotic therapy - No other prior malignancy in past 5 years except carcinoma in situ of the cervix or adequately treated basal cell carcinoma, excluding melanoma, breast cancer, and hypernephroma - No concurrent illness or medical condition which is a contraindication for corticosteroid therapy (e.g., active ulcer, unstable diabetes mellitus) - No motor or sensory neurotoxicity of grade 2 or greater - No psychological, familial, sociological, or geographical condition that would preclude study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GiuseppeGiaccone, Study Chair, EORTC Lung Cancer Cooperative Group
Antoni van Leeuwenhoekhuis
Amsterdam, , 1066 CX
Netherlands
Zaas Medisch Centrum
Zaandam, , 1502 DV
Netherlands
Leiden University Medical Center
Leiden, , 2300 CA
Netherlands
Ziekenhuis St Jansdal
Harderwijk, , 3840 AC
Netherlands
Longarts Dr. J.M. Smit Rynstate Hospital
ARNHEM, , 6800 TA
Netherlands
Sint Antonius Ziekenhuis
Nieuwegein, , 3435 CM
Netherlands
Vrije Universiteit Medisch Centrum
Amsterdam, , 1001HV
Netherlands
Oncologia Medica - Perugia
Perugia, , 06122
Italy
Leyenburg Ziekenhuis
's-Gravenhage (Den Haag, The Hague), , 2545 CH
Netherlands
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, , 02-781
Poland
Canisius-Wilhelmina Ziekenhuis
Nijmegen, , 6532 SZ
Netherlands
Twee Steden Ziekenhuis Vestiging Tilburg
Tilburg, , 5042 AD
Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, , 1091 HA
Netherlands
Sophia Ziekehuis
Zwolle, , 8000 GK
Netherlands
Royal Marsden Hospital
Sutton, England, SM2 5PT
United Kingdom
Weston Park Hospital
Sheffield, England, S1O 2SJ
United Kingdom
Thoraxklinik Rohrbach
Heidelberg, , D-69126
Germany
Slotervaart Ziekenhuis
Amsterdam, , 1066 EC
Netherlands
Groot Ziekengasthuis 's-Hertogenbosch
's-Hertogenbosch, , 5211 NL
Netherlands
Academisch Ziekenhuis Utrecht
Utrecht, , 3584 CX
Netherlands
University Hospital - Rotterdam Dijkzigt
Rotterdam, , 3000 CA
Netherlands
Istituto Nazionale per la Ricerca sul Cancro
Genoa (Genova), , 16132
Italy
University Medical Center Nijmegen
Nijmegen, , NL-6500 HB
Netherlands
Additional Information:
Study ID Numbers: CDR0000067901; EORTC-08984
Study Start Date: March 2000
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005868
Other Stage 3a Non-Small Cell Lung Cancer Studies:
1. Chemoradiotherapy Followed By Surgery and Docetaxel in Treating Patients With Pancoast Tumors
2. Combination Chemotherapy as Induction Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer
3. Combination Chemotherapy, Gefitinib, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer
4. Hospitalization Rates of Patients With Non-Small Cell Lung Cancer Treated With Gemcitabine and Either Cisplatin or Carboplatin
5. Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
Related Studies:
Other stage 3A non-small cell lung cancer Clinical Trials
Other Clinical Trials
Other ARNHEM Clinical Trials
Docetaxel and Cisplatin in Treating Patients With Untreated Stage IIIA Non-small Cell Lung Cancer
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