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Docetaxel and Cisplatin in Treating Patients With Untreated Stage IIIA Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.

Sponsored by: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005868
  Purpose

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

MedlinePlus related topics:   Cancer    Lung Cancer   

Drug Information available for:   Docetaxel    Cisplatin   

U.S. FDA Resources

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)

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   March 2000

Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility
Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified

Hematopoietic:

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

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

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005868

Locations
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

Sponsors and Collaborators
European Organization for Research and Treatment of Cancer

Investigators
Study Chair:     Giuseppe Giaccone, MD, PhD     Free University Medical Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:
Biesma B, Manegold C, Smit HJ, Willems L, Legrand C, Passioukov A, van Meerbeeck JP, Giaccone G; for the EORTC Lung Cancer Group. Docetaxel and cisplatin as induction chemotherapy in patients with pathologically-proven stage IIIA N2 non-small cell lung cancer: a phase II study of the European organization for research and treatment of cancer (EORTC 08984). Eur J Cancer. 2006 Jul;42(10):1399-406. Epub 2006 Jun 8.
 
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.
 

Study ID Numbers:   CDR0000067901, EORTC-08984
First Received:   June 2, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00005868
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IIIA non-small cell lung cancer  

Study placed in the following topic categories:
Docetaxel
Thoracic Neoplasms
Non-small cell lung cancer
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




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