Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan, cisplatin, and etoposide work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Cisplatin; Etoposide; Etoposide phosphate; Irinotecan

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

• Stage IIIA (N2) or IIIB disease

• Pathologic documentation of N2-3 mediastinal lymph nodes is encouraged but not required if nodal size is ≥ 1.5 cm in largest diameter

• No stage IIIB disease with malignant pleural effusion or superior sulcus tumor

• At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors

• Unresectable disease

• No known brain metastasis

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy > 3 months

• ANC ≥ 1,500/mm³

• Hemoglobin ≥ 9.0 g/dL (can be corrected by transfusion)

• Platelet count ≥ 100,000/mm³

• Creatinine < 1.5 mg/dL

• Total bilirubin < 2 times upper limit of normal (ULN)

• Transaminases < 3 times ULN

• Patient compliance and geographic proximity that allow adequate follow up

• No serious, uncontrolled systemic intercurrent illness (e.g., infections or poorly controlled diabetes)

• No history of significant neurological or mental disorder, including seizures or dementia

• No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer

• No active cardiac disease not controlled by therapy

• No myocardial infarction within the past 12 months

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or radiotherapy for NSCLC

• No other concurrent systemic chemotherapy, investigational drug, or radiotherapy