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	Treatment or Intervention	Phase
stage IIIA non-small cell lung cancer Squamous Cell Lung Cancer Adenocarcinoma of the Lung large cell lung cancer	Drug: cisplatin  Drug: docetaxel	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years   -   75 Years

Criteria

PROTOCOL ENTRY 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

--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

--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

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

Study chairs or principal investigators

Daniel C. Betticher,  Study Chair,  Swiss Institute for Applied Cancer Research   

Study ID Numbers:  CDR0000066100; SWS-SAKK-16/96; EU-97034
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003231
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08