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Combination Chemotherapy Followed by Surgery in Treating Patients With Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.

Sponsored by: Swiss Group for Clinical Cancer Research
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003231
  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 with surgery may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with docetaxel and cisplatin followed by surgery in treating patients with stage IIIA non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: cisplatin
Drug: docetaxel
Procedure: radiation therapy
Procedure: surgical procedure
Phase II

MedlinePlus related topics:   Cancer    Lung Cancer   

ChemIDplus related topics:   Cisplatin    Docetaxel   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Preoperative Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Patients With Mediastinal Lymph Node Metastases (Stage IIIA, N2)

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   40
Study Start Date:   April 1997

Detailed Description:

OBJECTIVES: I. Assess the efficacy and toxic effects of docetaxel plus cisplatin in patients with stage IIIA non-small cell lung cancer. II. Assess the clinical and pathological response rate to this therapy in this patient population. III. Compare the benefit of surgery in terms of overall survival of responding and nonresponding patients.

OUTLINE: Patients receive infusions of docetaxel over 1 hour on day 1, followed by infusions of cisplatin over 1 hour on days 1-2. Treatment is repeated for three 21 day courses. Patients undergo tumor resection and mediastinal lymph node dissection. Patients are to receive postoperative radiotherapy within 4 weeks of resection if the tumor reaches the resection margins and/or the first mediastinal lymph node levels are involved. Patients will be followed until death.

PROJECTED ACCRUAL: Approximately 5-40 patients will be accrued within 3 years.

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Histologically proven stage IIIA non-small cell lung cancer (NSCLC)(including squamous, adenocarcinoma, large cell, and poorly differentiated NSCLC) Nodal metastases of T1-3 N2 M0 No distant metastases

PATIENT CHARACTERISTICS: Age: 18 to 75 Performance Status: WHO 0-2 Life Expectancy: Not specified Hematopoietic: Leucocytes greater than 4,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin within normal limits AST or ALT no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine clearance greater than 60 mL/min No hypercalcemia Cardiovascular: No unstable cardiac disease No congestive heart failure No angina pectoris No significant arrhythmias No prior history of myocardial infarction within 3 months Pulmonary: Lung function test with a forced expiratory volume greater than 1.2 L/sec Neurologic: No dementia No peripheral neuropathy greater than grade 1 No psychosis No seizure disorders Other: No prior or concurrent malignancies, except: Nonmelanoma skin cancer Carcinoma in situ of the cervix No active uncontrolled infection or other serious medical conditions No diabetes mellitus treated with insulin No gastric ulcers

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: No prior corticosteroids or other endocrine therapy No concurrent treatment with prednisone (except for prophylaxis, treatment of acute hypersensitivity, or chronic treatment initiated greater than 6 months prior to study entry) Radiotherapy: No prior radiotherapy Surgery: No prior surgery for malignancy Other: No concurrent treatment with other experimental drugs No involvement in clinical trials within 30 days of study No prior treatment with other cytostatic therapy

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003231

Locations
Switzerland
Burgerspital, Solothurn    
      Solothurn, Switzerland, 4500
City Hospital Triemli    
      Zurich, Switzerland, 8063
Hopital Cantonal Universitaire de Geneva    
      Geneva, Switzerland, CH-1211
Inselspital, Bern    
      Bern, Switzerland, CH-3010
University Hospital    
      Basel, Switzerland, CH-4031
Kantonspital Aarau    
      Aarau, Switzerland, 5001
Klinik Hirslanden    
      Zurich, Switzerland, CH-8008
Office of Walter Weber-Stadelman    
      Basel, Switzerland, CH 4051
Istituto Oncologico della Svizzera Italiana    
      Lugano, Switzerland, CH-6900

Sponsors and Collaborators
Swiss Group for Clinical Cancer Research

Investigators
Study Chair:     Daniel C. Betticher, MD     University Hospital Inselspital, Berne    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000066100, SWS-SAKK-16/96, EU-97034
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003231
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
squamous cell lung cancer  
large cell lung cancer  
stage IIIA non-small cell lung cancer  
adenocarcinoma of the lung  

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Carcinoma
Docetaxel
Adenocarcinoma of lung
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Lung Diseases
Neoplasm Metastasis
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 16, 2008




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