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

Last Updated: 2009-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30

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.

Conditions

Lung Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

cisplatin

Intervention Type: DRUG

etoposide

Intervention Type: DRUG

irinotecan hydrochloride

Intervention Type: DRUG

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Principal Investigators

Joo-Hang Kim, MD

Role: STUDY_CHAIR

Yonsei University

Locations

Yonsei Cancer Center at Yonsei University Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

Joo-Hang Kim, MD

Role: primary

kjhang@yuhs.ac

+82-10-4507-6063

Other Identifiers

YONSEI-4-2007-0120

Identifier Type: -

Identifier Source: secondary_id

CDR0000584442

Identifier Type: -

Identifier Source: org_study_id