Docetaxel and Cisplatin in Treating Patients With Untreated Stage IIIA Non-small Cell Lung Cancer
NCT ID: NCT00005868
Last Updated: 2012-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
47 participants
INTERVENTIONAL
2000-03-31
Brief Summary
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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.
Detailed Description
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* 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
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Keywords
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Study Design
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TREATMENT
Interventions
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cisplatin
docetaxel
Eligibility Criteria
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Inclusion Criteria
* 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
19 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Giuseppe Giaccone, MD, PhD
Role: STUDY_CHAIR
Free University Medical Center
Locations
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Thoraxklinik Rohrbach
Heidelberg, , Germany
Istituto Nazionale per la Ricerca sul Cancro
Genoa (Genova), , Italy
Oncologia Medica - Perugia
Perugia, , Italy
Leyenburg Ziekenhuis
's-Gravenhage (Den Haag, the Hague), , Netherlands
Groot Ziekengasthuis 's-Hertogenbosch
's-Hertogenbosch, , Netherlands
Vrije Universiteit Medisch Centrum
Amsterdam, , Netherlands
Antoni van Leeuwenhoekhuis
Amsterdam, , Netherlands
Slotervaart Ziekenhuis
Amsterdam, , Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, , Netherlands
Longarts Dr. J.M. Smit Rynstate Hospital
Arnhem, , Netherlands
Ziekenhuis St Jansdal
Harderwijk, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Sint Antonius Ziekenhuis
Nieuwegein, , Netherlands
Canisius-Wilhelmina Ziekenhuis
Nijmegen, , Netherlands
University Medical Center Nijmegen
Nijmegen, , Netherlands
University Hospital - Rotterdam Dijkzigt
Rotterdam, , Netherlands
Twee Steden Ziekenhuis Vestiging Tilburg
Tilburg, , Netherlands
Academisch Ziekenhuis Utrecht
Utrecht, , Netherlands
Zaas Medisch Centrum
Zaandam, , Netherlands
Sophia Ziekehuis
Zwolle, , Netherlands
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, , Poland
Weston Park Hospital
Sheffield, England, United Kingdom
Royal Marsden Hospital
Sutton, England, United Kingdom
Countries
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References
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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.
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.
Other Identifiers
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EORTC-08984
Identifier Type: -
Identifier Source: secondary_id
EORTC-08984
Identifier Type: -
Identifier Source: org_study_id