Phase II Trial of Concurrent Cisplatin/Docetaxel and Radiotherapy Followed by Consolidation Docetaxel in Stage IIIB Non-Small Cell Lung Cancer
Phase II Trial of Concurrent Cisplatin/Docetaxel and Radiotherapy Followed by Consolidation Docetaxel in Stage IIIB Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have stage IIIB non-small cell lung cancer.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive induction chemotherapy comprising docetaxel IV over 30 minutes on days 1, 8, 15, 22, 29, and 36 and cisplatin IV over 60 minutes on days 1, 8, 29, and 36. Patients also undergo concurrent radiotherapy daily, 5 days per week, for 6.5 weeks.
At least 1 week and no more than 4 weeks after completion of induction chemoradiotherapy, patients with stable or responding disease receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 3 months for 1 year, and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 30 months.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed stage IIIB non-small cell lung cancer
Pathologically or radiographically documented positive N3 nodes
T4 tumor invading any of the following:
No brain, contralateral chest, liver, or adrenal metastases
No more than 1 parenchymal lesion
No malignant pleural effusions unless they are only visible on CT scan or deemed too small to tap
No pericardial effusions
Measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
One of the following:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Los Angeles, California 90033-0804, United States
Hines, Illinois 60141, United States
Lexington, Kentucky 40536-0084, United States
Shreveport, Louisiana 71130-3932, United States
Jamaica Plain, Massachusetts 02130, United States
San Antonio, Texas 78284-7845, United States