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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00005868
First received: June 2, 2000
Last updated: July 17, 2012
Last verified: July 2012
  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 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Taxotere and Cisplatin as Induction Chemotherapy in Patients With Stage IIIa N2 Non Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Enrollment: 47
Study Start Date: March 2000
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Slotervaart Ziekenhuis
Amsterdam, Netherlands, 1066 EC
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands, 1091 HA
Antoni van Leeuwenhoekhuis
Amsterdam, Netherlands, 1066 CX
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
University Medical Center Nijmegen
Nijmegen, Netherlands, NL-6500 HB
Canisius-Wilhelmina Ziekenhuis
Nijmegen, Netherlands, 6532 SZ
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
Poland
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
Investigators
Study Chair: Giuseppe Giaccone, MD, PhD Free University Medical Center
  More Information

Additional Information:
Publications:
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, EORTC-08984
Study First Received: June 2, 2000
Last Updated: July 17, 2012
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on August 20, 2014