Lung Cancer
Conditions
Keywords
stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
Brief 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.
Detailed description
OBJECTIVES: Primary * To evaluate the efficacy of induction chemotherapy comprising irinotecan hydrochloride and cisplatin in patients with locally advanced, unresectable stage III non-small cell lung cancer. * To evaluate the feasibility of radiotherapy administered concurrently with etoposide and cisplatin chemotherapy after induction chemotherapy in these patients. Secondary * To evaluate the toxicity of induction chemotherapy comprising irinotecan hydrochloride and cisplatin in these patients. * To assess whether this induction chemotherapy regimen will improve patient survival when compared with outcomes from the predecessor study, SWOG-9019. OUTLINE: Patients receive dose-dense induction chemotherapy comprising irinotecan hydrochloride IV and cisplatin IV on days 1 and 8. Treatment repeats every 21 days for up to 2 courses. After completion of induction chemotherapy, patients undergo radiotherapy five days a week for approximately 7 weeks. Patients receive concurrent chemotherapy comprising cisplatin IV on days 1, 8, 29, and 36 and etoposide IV on days 1-5 and 29-33. After completion of study therapy, patients are followed at 6 weeks.
Interventions
DRUGcisplatin
DRUGetoposide
DRUGirinotecan hydrochloride
RADIATIONradiation therapy
Sponsors
Yonsei University
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of local/regional control | — |
| Rate of systemic disease control | — |
| Feasibility of radiotherapy administered concurrently with etoposide and cisplatin chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity of irinotecan hydrochloride and cisplatin induction chemotherapy as assessed by NCI CTCAE v3.0 | — |
| Progression-free survival | — |
| Overall survival | — |
Countries
South Korea
Outcome results
None listed