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Cetuximab (C225) and Radiation in Elderly and /or Poor Performance Status Patients With Locally Advanced Non-Small Cell Lung Cancer: A Phase II Study to Evaluate Survival and Toxicity

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Cetuximab (C225) and Radiation in Elderly and /or Poor Performance Status Patients With Locally Advanced Non-Small Cell Lung Cancer: A Phase II Study to Evaluate Survival and Toxicity



- 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


- 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

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

Inclusion Criteria


- 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



- 18 and over

Performance status

- ECOG 0-2 (age ≥ 65 years)

- ECOG 2 (age 18 to 64 years)

Life expectancy

- At least 12 weeks


- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 g/dL


- Bilirubin ≤ 2 times upper limit of normal (ULN)

- AST ≤ 3 times ULN


- Creatinine ≤ 1.5 times ULN


- FEV_1 ≥ 1 L

- No idiopathic pulmonary fibrosis


- 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


Biologic therapy

- Not specified


- See Disease Characteristics

- No prior chemotherapy for NSCLC

Endocrine therapy

- Not specified


- No prior therapeutic radiotherapy to the chest

- No concurrent intensity modulated radiotherapy


- Not specified


- No prior epidermal growth factor receptor inhibitors

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

11-month survival rate

Safety Issue:


Principal Investigator

Aminah Jatoi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

January 2006

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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