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

Sponsor

Yonsei University (Other)

Overall Status

Unknown status

CT.gov ID

NCT00616785

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: cisplatin Drug: etoposide Drug: irinotecan hydrochloride Radiation: radiation therapy	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

41 participants

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2007

Anticipated Primary Completion Date :

Nov 1, 2010

Outcome Measures

Primary Outcome Measures

Rate of local/regional control []
Rate of systemic disease control []
Feasibility of radiotherapy administered concurrently with etoposide and cisplatin chemotherapy []

Secondary Outcome Measures

Toxicity of irinotecan hydrochloride and cisplatin induction chemotherapy as assessed by NCI CTCAE v3.0 []
Progression-free survival []
Overall survival []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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