Phase II Trial Irinotecan and Cisplatin Induction Chemotherapy Followed by Radiotherapy Concurrently With Etoposide/Cisplatin in Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer
18 Years
75 Years
Both
Lung Cancer
Trial Information
Phase II Trial Irinotecan and Cisplatin Induction Chemotherapy Followed by Radiotherapy Concurrently With Etoposide/Cisplatin in Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer
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.
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Rate of local/regional control
Safety Issue:
No
Principal Investigator
Joo-Hang Kim, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Yonsei University
Authority:
Unspecified
Study ID:
CDR0000584442
NCT ID:
NCT00616785
Start Date:
June 2007
Completion Date:
Related Keywords:
- Lung Cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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