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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
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

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

Detailed Description:


  • 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
Primary Purpose: 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
Primary Completion Date : August 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • Over 18

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • 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


  • Creatinine no greater than 1.25 ULN
  • Creatinine clearance at least 60 mL/min


  • No superior vena cava syndrome
  • No uncontrolled congestive heart failure or angina
  • No myocardial infarction within past year
  • No uncontrolled hypertension or arrhythmia


  • 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


Biologic therapy:

  • No concurrent immunotherapy


  • No prior chemotherapy for NSCLC
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy


  • No prior radiotherapy for NSCLC
  • No concurrent radiotherapy


  • No prior surgery for NSCLC


  • At least 1 month since prior investigational agents
  • No other concurrent experimental medications

Information from the National Library of Medicine

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

Thoraxklinik Rohrbach
Heidelberg, Germany, D-69126
Istituto Nazionale per la Ricerca sul Cancro
Genoa (Genova), Italy, 16132
Oncologia Medica - Perugia
Perugia, Italy, 06122
Leyenburg Ziekenhuis
'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
Slotervaart Ziekenhuis
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
Canisius-Wilhelmina Ziekenhuis
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
Sophia Ziekehuis
Zwolle, Netherlands, 8000 GK
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, Poland, 02-781
United Kingdom
Weston Park Hospital
Sheffield, England, United Kingdom, S1O 2SJ
Royal Marsden Hospital
Sutton, England, United Kingdom, SM2 5PT
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Study Chair: Giuseppe Giaccone, MD, PhD Free University Medical Center

Manegold C, Biesma B, Smit H, et al.: Docetaxel and cisplatin as induction chemotherapy in stage IIIA N2 non-small cell lung cancer (NSCLC): an EORTC phase II trial (08984). [Abstract] J Clin Oncol 22 (Suppl 14): A-7166, 657s, 2004.
Manegold C, Biesma B, Debruyne C, et al.: Docetaxel and cisplatin as induction chemotherapy in stage IIIA N2 non-small cell lung cancer (NSCLC): an EORTC phase II trial (08984). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-2719, 2002.

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00005868     History of Changes
Other Study ID Numbers: EORTC-08984
First Posted: May 21, 2003    Key Record Dates
Last Update Posted: July 18, 2012
Last Verified: July 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage IIIA non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action