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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.
First Received: June 2, 2000   Last Updated: July 23, 2008   History of Changes
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: Cisplatin Docetaxel
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

Additional Information:
Publications:
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
Study First Received: June 2, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00005868     History of Changes
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
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009