Clincosm LogoSign in Get a demo

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

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC (Other)
Overall Status
Completed
CT.gov ID
NCT00005868
Collaborator
(none)
47
Enrollment
23
Locations
2
Patients Per Site

Study Details

Study Description

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
Phase 2

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.

Study Design

Study Type:
Interventional
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 :
Mar 1, 2000
Actual Primary Completion Date :
Aug 1, 2002

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Thoraxklinik Rohrbach Heidelberg Germany D-69126
    2 Istituto Nazionale per la Ricerca sul Cancro Genoa (Genova) Italy 16132
    3 Oncologia Medica - Perugia Perugia Italy 06122
    4 Leyenburg Ziekenhuis 's-Gravenhage (Den Haag, The Hague) Netherlands 2545 CH
    5 Groot Ziekengasthuis 's-Hertogenbosch 's-Hertogenbosch Netherlands 5211 NL
    6 Vrije Universiteit Medisch Centrum Amsterdam Netherlands 1001HV
    7 Antoni van Leeuwenhoekhuis Amsterdam Netherlands 1066 CX
    8 Slotervaart Ziekenhuis Amsterdam Netherlands 1066 EC
    9 Onze Lieve Vrouwe Gasthuis Amsterdam Netherlands 1091 HA
    10 Longarts Dr. J.M. Smit Rynstate Hospital Arnhem Netherlands 6800 TA
    11 Ziekenhuis St Jansdal Harderwijk Netherlands 3840 AC
    12 Leiden University Medical Center Leiden Netherlands 2300 CA
    13 Sint Antonius Ziekenhuis Nieuwegein Netherlands 3435 CM
    14 Canisius-Wilhelmina Ziekenhuis Nijmegen Netherlands 6532 SZ
    15 University Medical Center Nijmegen Nijmegen Netherlands NL-6500 HB
    16 University Hospital - Rotterdam Dijkzigt Rotterdam Netherlands 3000 CA
    17 Twee Steden Ziekenhuis Vestiging Tilburg Tilburg Netherlands 5042 AD
    18 Academisch Ziekenhuis Utrecht Utrecht Netherlands 3584 CX
    19 Zaas Medisch Centrum Zaandam Netherlands 1502 DV
    20 Sophia Ziekehuis Zwolle Netherlands 8000 GK
    21 Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Warsaw Poland 02-781
    22 Weston Park Hospital Sheffield England United Kingdom S1O 2SJ
    23 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    European Organisation for Research and Treatment of Cancer - EORTC
    ClinicalTrials.gov Identifier:
    NCT00005868
    Other Study ID Numbers:
    • EORTC-08984
    • EORTC-08984
    First Posted:
    May 21, 2003
    Last Update Posted:
    Jul 18, 2012
    Last Verified:
    Jul 1, 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
    Docetaxel

    Study Results

    No Results Posted as of Jul 18, 2012