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Sponsored by: |
European Organization for Research and Treatment of Cancer |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005868 |
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.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: cisplatin Drug: docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Taxotere and Cisplatin as Induction Chemotherapy in Patients With Stage IIIa N2 Non Small Cell Lung Cancer (NSCLC) |
Study Start Date: | March 2000 |
OBJECTIVES:
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.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed stage IIIA non-small cell lung cancer (NSCLC) (T1-3, N2, M0)
Measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Germany | |
Thoraxklinik Rohrbach | |
Heidelberg, Germany, D-69126 | |
Italy | |
Istituto Nazionale per la Ricerca sul Cancro | |
Genoa (Genova), Italy, 16132 | |
Oncologia Medica - Perugia | |
Perugia, Italy, 06122 | |
Netherlands | |
Academisch Ziekenhuis Utrecht | |
Utrecht, Netherlands, 3584 CX | |
Antoni van Leeuwenhoekhuis | |
Amsterdam, Netherlands, 1066 CX | |
Onze Lieve Vrouwe Gasthuis | |
Amsterdam, Netherlands, 1091 HA | |
Groot Ziekengasthuis 's-Hertogenbosch | |
's-Hertogenbosch, Netherlands, 5211 NL | |
Leiden University Medical Center | |
Leiden, Netherlands, 2300 CA | |
Leyenburg Ziekenhuis | |
's-Gravenhage (Den Haag, The Hague), Netherlands, 2545 CH | |
Longarts Dr. J.M. Smit Rynstate Hospital | |
Arnhem, Netherlands, 6800 TA | |
Canisius-Wilhelmina Ziekenhuis | |
Nijmegen, Netherlands, 6532 SZ | |
Sint Antonius Ziekenhuis | |
Nieuwegein, Netherlands, 3435 CM | |
Slotervaart Ziekenhuis | |
Amsterdam, Netherlands, 1066 EC | |
Sophia Ziekehuis | |
Zwolle, Netherlands, 8000 GK | |
Twee Steden Ziekenhuis Vestiging Tilburg | |
Tilburg, Netherlands, 5042 AD | |
University Hospital - Rotterdam Dijkzigt | |
Rotterdam, Netherlands, 3000 CA | |
University Medical Center Nijmegen | |
Nijmegen, Netherlands, NL-6500 HB | |
Vrije Universiteit Medisch Centrum | |
Amsterdam, Netherlands, 1001HV | |
Zaas Medisch Centrum | |
Zaandam, Netherlands, 1502 DV | |
Ziekenhuis St Jansdal | |
Harderwijk, Netherlands, 3840 AC | |
Poland | |
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology | |
Warsaw, Poland, 02-781 | |
United Kingdom, England | |
Royal Marsden Hospital | |
Sutton, England, United Kingdom, SM2 5PT | |
Weston Park Hospital | |
Sheffield, England, United Kingdom, S1O 2SJ |
Study Chair: | Giuseppe Giaccone, MD, PhD | Free University Medical Center |
Study ID Numbers: | CDR0000067901, EORTC-08984 |
Study First Received: | June 2, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005868 History of Changes |
Health Authority: | United States: Federal Government |
stage IIIA non-small cell lung cancer |
Docetaxel Thoracic Neoplasms Radiation-Sensitizing Agents Cisplatin Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Physiological Effects of Drugs Pharmacologic Actions Carcinoma Docetaxel Neoplasms |
Neoplasms by Site Radiation-Sensitizing Agents Respiratory Tract Diseases Cisplatin Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |