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Lung CancerPhase 2NCT00005868

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

A Phase 2 study testing cisplatin and docetaxel in people with Lung Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 23 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Lung Cancer
What is being tested?
cisplatin and docetaxel
How many people
47 participants
Where
23 sitesin 5 countries
Study dates
Mar 2000to Aug 2002
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

23 sites in 5 countries.

23 sites in 5 countries

Netherlands17 sites

  • Leyenburg Ziekenhuis

    's-Gravenhage (Den Haag, the Hague), 2545 CH

  • Groot Ziekengasthuis 's-Hertogenbosch

    's-Hertogenbosch, 5211 NL

  • Vrije Universiteit Medisch Centrum

    Amsterdam, 1001HV

  • Antoni van Leeuwenhoekhuis

    Amsterdam, 1066 CX

  • Slotervaart Ziekenhuis

    Amsterdam, 1066 EC

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 HA

  • Longarts Dr. J.M. Smit Rynstate Hospital

    Arnhem, 6800 TA

  • Ziekenhuis St Jansdal

    Harderwijk, 3840 AC

  • Leiden University Medical Center

    Leiden, 2300 CA

  • Sint Antonius Ziekenhuis

    Nieuwegein, 3435 CM

  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen, 6532 SZ

  • University Medical Center Nijmegen

    Nijmegen, NL-6500 HB

  • University Hospital - Rotterdam Dijkzigt

    Rotterdam, 3000 CA

  • Twee Steden Ziekenhuis Vestiging Tilburg

    Tilburg, 5042 AD

  • Academisch Ziekenhuis Utrecht

    Utrecht, 3584 CX

  • Zaas Medisch Centrum

    Zaandam, 1502 DV

  • Sophia Ziekehuis

    Zwolle, 8000 GK

Other trials in Netherlands

Italy2 sites

  • Istituto Nazionale per la Ricerca sul Cancro

    Genoa (Genova), 16132

  • Oncologia Medica - Perugia

    Perugia, 06122

Other trials in Italy

United Kingdom2 sites

  • Weston Park Hospital

    Sheffield, England, S1O 2SJ

  • Royal Marsden Hospital

    Sutton, England, SM2 5PT

Other trials in United Kingdom

Germany1 site

  • Thoraxklinik Rohrbach

    Heidelberg, D-69126

Other trials in Germany

Poland1 site

  • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

    Warsaw, 02-781

Other trials in Poland

About this study

Official title: Taxotere and Cisplatin as Induction Chemotherapy in Patients With Stage IIIa N2 Non Small Cell Lung Cancer (NSCLC)

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.

Read the 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.

Conditions
Lung Cancer
Being tested
cisplatin, docetaxel
Keywords
stage IIIA non-small cell lung cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2003 (estimated)
  2. Study startMar 2000
  3. Primary completionAug 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005868
Sponsor's protocol ID
EORTC-08984
Other IDs
EORTC-08984
Status last verified
Jul 2012
First submitted
2 Jun 2000
Last updated
18 Jul 2012
Results posted
No

Publications

  • Biesma B, Manegold C, Smit HJ, Willems L, Legrand C, Passioukov A, van Meerbeeck JP, Giaccone G; 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. doi: 10.1016/j.ejca.2006.01.049. Epub 2006 Jun 8.

    PubMed 16759850

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin and docetaxel in people with Lung Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 23 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Netherlands, Italy, United Kingdom, Germany, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005868, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2012.

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