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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005868
• Other study ID #: EORTC-08984
• Secondary ID: EORTC-08984
• Status: Completed
• Phase: Phase 2
• First received: June 2, 2000
• Last updated: July 17, 2012
• Start date: March 2000

Study information

• Verified date: July 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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 lung cancer.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. primary completion date: August 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• cisplatin

• docetaxel

Locations

Country	Name	City	State
Germany	Thoraxklinik Rohrbach	Heidelberg
Italy	Istituto Nazionale per la Ricerca sul Cancro	Genoa (Genova)
Italy	Oncologia Medica - Perugia	Perugia
Netherlands	Leyenburg Ziekenhuis	's-Gravenhage (Den Haag, The Hague)
Netherlands	Groot Ziekengasthuis 's-Hertogenbosch	's-Hertogenbosch
Netherlands	Antoni van Leeuwenhoekhuis	Amsterdam
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam
Netherlands	Slotervaart Ziekenhuis	Amsterdam
Netherlands	Vrije Universiteit Medisch Centrum	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
Poland	Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology	Warsaw
United Kingdom	Weston Park Hospital	Sheffield	England
United Kingdom	Royal Marsden Hospital	Sutton	England

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Germany,  Italy,  Netherlands,  Poland,  United Kingdom, 

References & Publications (3)

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 — View Citation

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-271

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.