Overview

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

Status:
Completed
Trial end date:
2000-09-01
Target enrollment:
0
Participant gender:
All
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 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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Swiss Group for Clinical Cancer Research
Treatments:
Docetaxel
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