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

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

NCT ID: NCT00616785

Condition: Lung Cancer

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Irinotecan
Etoposide

Conditions: Keywords:
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Study type: Interventional

Study phase: Phase 2

Overall status: Unknown status

Study design:

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: cisplatin

Intervention type: Drug
Intervention name: etoposide

Intervention type: Drug
Intervention name: irinotecan hydrochloride

Intervention type: Radiation
Intervention name: radiation therapy

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.

Criteria for eligibility:
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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Yonsei Cancer Center at Yonsei University Medical Center

Address:
City: Seoul
Zip: 120-752
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Joo-Hang Kim, MD

Phone: +82-10-4507-6063
Email: kjhang@yuhs.ac

Start date: June 2007

Lead sponsor:
Agency: Yonsei University
Agency class: Other

Source: National Cancer Institute (NCI)

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT00616785