Docetaxel and Cisplatin in Treating Patients With Untreated Stage IIIA Non-small Cell Lung Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: cisplatin Drug: docetaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Taxotere and Cisplatin as Induction Chemotherapy in Patients With Stage IIIa N2 Non Small Cell Lung Cancer (NSCLC) |
| Enrollment: | 47 |
| Study Start Date: | March 2000 |
| Primary Completion Date: | August 2002 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| 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| Germany | |
| Thoraxklinik Rohrbach | |
| Heidelberg, Germany, D-69126 | |
| Italy | |
| Istituto Nazionale per la Ricerca sul Cancro | |
| Genoa (Genova), Italy, 16132 | |
| Oncologia Medica - Perugia | |
| Perugia, Italy, 06122 | |
| Netherlands | |
| Leyenburg Ziekenhuis | |
| 's-Gravenhage (Den Haag, The Hague), Netherlands, 2545 CH | |
| Groot Ziekengasthuis 's-Hertogenbosch | |
| 's-Hertogenbosch, Netherlands, 5211 NL | |
| Vrije Universiteit Medisch Centrum | |
| Amsterdam, Netherlands, 1001HV | |
| Slotervaart Ziekenhuis | |
| Amsterdam, Netherlands, 1066 EC | |
| Onze Lieve Vrouwe Gasthuis | |
| Amsterdam, Netherlands, 1091 HA | |
| Antoni van Leeuwenhoekhuis | |
| Amsterdam, Netherlands, 1066 CX | |
| Longarts Dr. J.M. Smit Rynstate Hospital | |
| Arnhem, Netherlands, 6800 TA | |
| Ziekenhuis St Jansdal | |
| Harderwijk, Netherlands, 3840 AC | |
| Leiden University Medical Center | |
| Leiden, Netherlands, 2300 CA | |
| Sint Antonius Ziekenhuis | |
| Nieuwegein, Netherlands, 3435 CM | |
| University Medical Center Nijmegen | |
| Nijmegen, Netherlands, NL-6500 HB | |
| Canisius-Wilhelmina Ziekenhuis | |
| Nijmegen, Netherlands, 6532 SZ | |
| University Hospital - Rotterdam Dijkzigt | |
| Rotterdam, Netherlands, 3000 CA | |
| Twee Steden Ziekenhuis Vestiging Tilburg | |
| Tilburg, Netherlands, 5042 AD | |
| Academisch Ziekenhuis Utrecht | |
| Utrecht, Netherlands, 3584 CX | |
| Zaas Medisch Centrum | |
| Zaandam, Netherlands, 1502 DV | |
| Sophia Ziekehuis | |
| Zwolle, Netherlands, 8000 GK | |
| Poland | |
| Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology | |
| Warsaw, Poland, 02-781 | |
| United Kingdom | |
| Weston Park Hospital | |
| Sheffield, England, United Kingdom, S1O 2SJ | |
| Royal Marsden Hospital | |
| Sutton, England, United Kingdom, SM2 5PT | |
| Study Chair: | Giuseppe Giaccone, MD, PhD | Free University Medical Center |
More Information
Additional Information:
Publications:
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00005868 History of Changes |
| Other Study ID Numbers: | EORTC-08984, EORTC-08984 |
| Study First Received: | June 2, 2000 |
| Last Updated: | July 17, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
stage IIIA non-small cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases |
Respiratory Tract Diseases Docetaxel Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013