Docetaxel and Cisplatin in Treating Patients With Untreated Stage IIIA Non-small Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00005868|
Recruitment Status : Completed
First Posted : May 21, 2003
Last Update Posted : July 18, 2012
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 or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: cisplatin Drug: docetaxel||Phase 2|
- Assess the therapeutic activity of docetaxel and cisplatin in patients with untreated stage IIIA non-small cell lung cancer.
- Determine the safety of this regimen in these patients.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|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|
|Actual Primary Completion Date :||August 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005868
|Heidelberg, Germany, D-69126|
|Istituto Nazionale per la Ricerca sul Cancro|
|Genoa (Genova), Italy, 16132|
|Oncologia Medica - Perugia|
|Perugia, Italy, 06122|
|'s-Gravenhage (Den Haag, The Hague), Netherlands, 2545 CH|
|Groot Ziekengasthuis 's-Hertogenbosch|
|'s-Hertogenbosch, Netherlands, 5211 NL|
|Vrije Universiteit Medisch Centrum|
|Amsterdam, Netherlands, 1001HV|
|Antoni van Leeuwenhoekhuis|
|Amsterdam, Netherlands, 1066 CX|
|Amsterdam, Netherlands, 1066 EC|
|Onze Lieve Vrouwe Gasthuis|
|Amsterdam, Netherlands, 1091 HA|
|Longarts Dr. J.M. Smit Rynstate Hospital|
|Arnhem, Netherlands, 6800 TA|
|Ziekenhuis St Jansdal|
|Harderwijk, Netherlands, 3840 AC|
|Leiden University Medical Center|
|Leiden, Netherlands, 2300 CA|
|Sint Antonius Ziekenhuis|
|Nieuwegein, Netherlands, 3435 CM|
|Nijmegen, Netherlands, 6532 SZ|
|University Medical Center Nijmegen|
|Nijmegen, Netherlands, NL-6500 HB|
|University Hospital - Rotterdam Dijkzigt|
|Rotterdam, Netherlands, 3000 CA|
|Twee Steden Ziekenhuis Vestiging Tilburg|
|Tilburg, Netherlands, 5042 AD|
|Academisch Ziekenhuis Utrecht|
|Utrecht, Netherlands, 3584 CX|
|Zaas Medisch Centrum|
|Zaandam, Netherlands, 1502 DV|
|Zwolle, Netherlands, 8000 GK|
|Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology|
|Warsaw, Poland, 02-781|
|Weston Park Hospital|
|Sheffield, England, United Kingdom, S1O 2SJ|
|Royal Marsden Hospital|
|Sutton, England, United Kingdom, SM2 5PT|
|Study Chair:||Giuseppe Giaccone, MD, PhD||Free University Medical Center|