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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
cisplatin
docetaxel
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIA non-small cell lung cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Thoraxklinik Rohrbach
  • Istituto Nazionale per la Ricerca sul Cancro
  • Oncologia Medica - Perugia
  • Leyenburg Ziekenhuis
  • Groot Ziekengasthuis 's-Hertogenbosch
  • Vrije Universiteit Medisch Centrum
  • Antoni van Leeuwenhoekhuis
  • Slotervaart Ziekenhuis
  • Onze Lieve Vrouwe Gasthuis
  • Longarts Dr. J.M. Smit Rynstate Hospital
  • Ziekenhuis St Jansdal
  • Leiden University Medical Center
  • Sint Antonius Ziekenhuis
  • Canisius-Wilhelmina Ziekenhuis
  • University Medical Center Nijmegen
  • University Hospital - Rotterdam Dijkzigt
  • Twee Steden Ziekenhuis Vestiging Tilburg
  • Academisch Ziekenhuis Utrecht
  • Zaas Medisch Centrum
  • Sophia Ziekehuis
  • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
  • Weston Park Hospital
  • Royal Marsden Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 2, 2000
Last Updated
July 17, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00005868
Brief Title
Docetaxel and Cisplatin in Treating Patients With Untreated Stage IIIA Non-small Cell Lung Cancer
Official Title
Taxotere and Cisplatin as Induction Chemotherapy in Patients With Stage IIIa N2 Non Small Cell Lung Cancer (NSCLC)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
March 2000 (undefined)
Primary Completion Date
August 2002 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage IIIA non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
docetaxel

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Giaccone, MD, PhD
Organizational Affiliation
Free University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Thoraxklinik Rohrbach
City
Heidelberg
ZIP/Postal Code
D-69126
Country
Germany
Facility Name
Istituto Nazionale per la Ricerca sul Cancro
City
Genoa (Genova)
ZIP/Postal Code
16132
Country
Italy
Facility Name
Oncologia Medica - Perugia
City
Perugia
ZIP/Postal Code
06122
Country
Italy
Facility Name
Leyenburg Ziekenhuis
City
's-Gravenhage (Den Haag, The Hague)
ZIP/Postal Code
2545 CH
Country
Netherlands
Facility Name
Groot Ziekengasthuis 's-Hertogenbosch
City
's-Hertogenbosch
ZIP/Postal Code
5211 NL
Country
Netherlands
Facility Name
Vrije Universiteit Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1001HV
Country
Netherlands
Facility Name
Antoni van Leeuwenhoekhuis
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Slotervaart Ziekenhuis
City
Amsterdam
ZIP/Postal Code
1066 EC
Country
Netherlands
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
ZIP/Postal Code
1091 HA
Country
Netherlands
Facility Name
Longarts Dr. J.M. Smit Rynstate Hospital
City
Arnhem
ZIP/Postal Code
6800 TA
Country
Netherlands
Facility Name
Ziekenhuis St Jansdal
City
Harderwijk
ZIP/Postal Code
3840 AC
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2300 CA
Country
Netherlands
Facility Name
Sint Antonius Ziekenhuis
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Canisius-Wilhelmina Ziekenhuis
City
Nijmegen
ZIP/Postal Code
6532 SZ
Country
Netherlands
Facility Name
University Medical Center Nijmegen
City
Nijmegen
ZIP/Postal Code
NL-6500 HB
Country
Netherlands
Facility Name
University Hospital - Rotterdam Dijkzigt
City
Rotterdam
ZIP/Postal Code
3000 CA
Country
Netherlands
Facility Name
Twee Steden Ziekenhuis Vestiging Tilburg
City
Tilburg
ZIP/Postal Code
5042 AD
Country
Netherlands
Facility Name
Academisch Ziekenhuis Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Zaas Medisch Centrum
City
Zaandam
ZIP/Postal Code
1502 DV
Country
Netherlands
Facility Name
Sophia Ziekehuis
City
Zwolle
ZIP/Postal Code
8000 GK
Country
Netherlands
Facility Name
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Weston Park Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S1O 2SJ
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
16759850
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
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-2719, 2002.
Results Reference
result

Learn more about this trial

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

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