Cetuximab and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 2

Conditions: Lung Cancer

Treatments: Biological: cetuximab; Radiation: radiation therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00124618

NCCTG-N0422

CDR0000435991 (Registry Identifier)

NCI-2012-02664 (Registry Identifier)

Details and patient eligibility

About

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with radiation therapy works in treating patients with stage III non-small cell lung cancer.

Full description

OBJECTIVES:

Primary

* Determine the 11 month survival rate in older and/or poor performance status patients with stage IIIA or stage IIIB non-small cell lung cancer treated with cetuximab and radiotherapy.

Secondary

• Determine the tumor response rate, overall survival, and time to disease progression in patients treated with this regimen.
• Determine the toxicity of this regimen in these patients.
• Determine whether fear of death is less severe in the oldest of patients treated with this regimen.
• Determine whether fear of death predicts survival of patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, and 43. Beginning on day 8, patients receive concurrent radiotherapy once daily on days 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed within 1 week, at 1 and 4 months, and then every 3 months for up to 3 years.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 20 months

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

  • Stage IIIA or IIIB disease

• Must be a candidate for curative radiotherapy

• Not a candidate for other concurrent chemotherapy and radiotherapy

• No surgical treatment available

• No pleural effusion suspected or proven to be malignant

• No stage IV disease by bone scan or positron emission tomography scan, CT scan or MRI of the brain, and CT scan of the chest within the past 30 days

PATIENT CHARACTERISTICS:

Age * 18 and over

Performance status

• Eastern Cooperative Oncology Group (ECOG) 0-2 (age ≥ 65 years)
• ECOG 2 (age 18 to 64 years)

Life expectancy

* At least 12 weeks

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 9 g/dL

Hepatic

• Bilirubin ≤ 2 times upper limit of normal (ULN)
• AST ≤ 3 times ULN

Renal

• Creatinine ≤ 1.5 times ULN

Pulmonary

• FEV_1 ≥ 1 L
• No idiopathic pulmonary fibrosis

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Magnesium normal
• No uncontrolled infection
• No other severe underlying disease that would preclude study entry
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma
• No major psychiatric illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

• See Disease Characteristics
• No prior chemotherapy for NSCLC

Endocrine therapy

* Not specified

Radiotherapy

• No prior therapeutic radiotherapy to the chest
• No concurrent intensity modulated radiotherapy

Other

* No prior epidermal growth factor receptor inhibitors

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

cetuximab/Radiation

Experimental group

Description:

Cetuximab (C225) and Radiation

Treatment:

Biological: cetuximab

Radiation: radiation therapy