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A Phase II Study Of Cetuximab (C225) In Combination With Chemoradiation In Patients With Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

A Phase II Study Of Cetuximab (C225) In Combination With Chemoradiation In Patients With Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)



- Determine the feasibility of cetuximab when administered concurrently with paclitaxel,
carboplatin, and radiotherapy, in terms of safety and compliance, in patients with
unresectable stage IIIA or IIIB non-small cell lung cancer.


- Determine the response rate (complete and partial) in patients treated with this

- Determine the overall survival (1- and 2-year survival rate and median survival) of
patients treated with this regimen.

- Determine the time to disease progression (at 1 and 2 years) in patients treated with
this regimen.

- Correlate epidermal growth factor receptor expression with the toxicity of this regimen
and response, overall survival, and progression in these patients.

OUTLINE: This is a multicenter study.

- Cetuximab loading dose (week 1): Patients receive a loading dose of cetuximab IV over 2
hours on day 1.

- Concurrent cetuximab and chemoradiotherapy (weeks 2-8): Patients receive cetuximab IV
over 1 hour, paclitaxel IV over 1 hour, and carboplatin IV over 30 minutes on days 8,
15, 22, 29, 36, 43, and 50. Patients undergo radiotherapy once daily on days 8-12,
15-19, 22-26, 29-33, 36-40, 43-47, and 50-53.

- Consolidation therapy (weeks 9-17): Patients receive cetuximab IV over 1 hour on days
57, 64, 71, 78, 85, 92, 99, 106, and 113. Patients also receive paclitaxel IV over 3
hours and carboplatin IV over 30 minutes on days 78 and 99.

Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed at 30 days, every 3 months for 2 years, every 4 months for 2 years,
and then annually thereafter.

PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study within 1 year.

Inclusion Criteria


- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of 1 of
the following subtypes:

- Squamous cell carcinoma

- Adenocarcinoma (including bronchoalveolar cell)

- Large cell anaplastic carcinoma (including giant and clear cell carcinomas)

- Poorly differentiated/not otherwise specified NSCLC

- Stage IIIA (T1-2, N2, M0 or T3, N1-2, M0) or IIIB (T4, any N, M0 or any T, N2-3, M0)

- If the largest mediastinal node is < 2.0 cm in diameter and this is the basis
for stage III disease, then at least 1 of the nodes must be cytologically or
histologically positive

- Unresectable disease

- No totally resected tumors

- Tumors adjacent to a vertebral body allowed provided all gross disease can be
encompassed in the radiation boost field and the boost volume is limited to < 50% of
the ipsilateral lung volume

- Measurable disease

- Transudate, cytologically negative, non-bloody pleural effusions allowed provided the
tumor can be encompassed within a reasonable field of radiotherapy

- Pleural effusions seen on a chest CT scan are allowed provided they are not
visible on a chest x-ray and are too small to tap

- No asymptomatic or symptomatic brain metastases



- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified


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

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 g/dL (transfusion independent)


- Bilirubin ≤ 1.5 mg/dL

- SGOT or SGPT ≤ 3 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2.5 times ULN


- Creatinine ≤ 2.0 mg/dL


- No significant history of cardiac disease

- No uncontrolled hypertension

- No unstable angina

- No uncompensated congestive heart failure

- No myocardial infarction within the past year

- No cardiac ventricular arrhythmias requiring medication

- LVEF normal by MUGA or echocardiogram


- No history of interstitial pneumonitis

- No history of severe chronic obstructive pulmonary disease requiring 3 or more
hospitalizations within the past year

- FEV_1 ≥ 1,200 cc

- No active pulmonary infection unresponsive to conventional antibiotics


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 4 weeks after study

- Glucose ≤ 2 times ULN

- No more than 5% weight loss within the past 3 months

- No known allergy to murine proteins or Cremophor EL

- No neuropathy grade 2 or greater

- No other malignancy within the past 2 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or other in situ cancers


Biologic therapy

- No prior drugs that target the epidermal growth factor receptor pathway

- No prior chimerized monoclonal antibody therapy

- No other concurrent immunotherapy

- No concurrent colony-stimulating factors (i.e., filgrastim [G-CSF] and sargramostim

- Concurrent epoetin alfa allowed


- No prior systemic chemotherapy

- No other concurrent chemotherapy

Endocrine therapy

- No concurrent hormonal therapy except hormones for non-disease-related conditions
(e.g., insulin for diabetes) or steroids for acute symptom management, adrenal
failure, septic shock, or as antiemetics


- No prior thoracic or neck radiotherapy

- No concurrent intensity-modulated radiotherapy


- Recovered from prior exploratory thoracotomy

- No prior surgical resection of the present cancer


- More than 30 days since prior participation in another clinical trial

- No concurrent participation in another clinical trial

- No other concurrent anticancer therapy

- No amifostine during or for 3 months after study radiotherapy

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

George R. Blumenschein, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:




Start Date:

March 2004

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • squamous cell lung cancer
  • large cell lung cancer
  • adenocarcinoma of the lung
  • bronchoalveolar cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Arlington Cancer Center - Arlington Arlington, Texas  76012