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Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
Conditions
Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: cisplatin
Type: Drug
Name: etoposide
Type: Drug
Name: irinotecan hydrochloride
Type: Drug
Name: radiation therapy
Type: Radiation
Overall Status
Recruiting
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.
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
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
- 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
Location
Yonsei Cancer Center at Yonsei University Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: Joo-Hang Kim, MD - +82-10-4507-6063 - kjhang@yuhs.ac
Start Date
June 2007
Sponsors
Yonsei University
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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