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A Randomized Phase II Study of Radiation Therapy, Pemetrexed and Carboplatin With or Without Cetuximab in Stage III Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

A Randomized Phase II Study of Radiation Therapy, Pemetrexed and Carboplatin With or Without Cetuximab in Stage III Non-Small Cell Lung Cancer



- Determine the overall survival of patients with unresectable stage III non-small cell
lung cancer treated with pemetrexed disodium, carboplatin, and thoracic radiotherapy
with or without cetuximab.


- Determine the failure-free survival and response rates in patients treated with these

- Correlate epidermal growth factor receptor, erbB2, and K-ras mutations with survival
and tumor response in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study.

- Chemoradiotherapy (courses 1-4): Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive pemetrexed disodium IV over 10 minutes followed by
carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo
thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40,
and 43-47.

- Arm II: Patients receive pemetrexed disodium, carboplatin, and thoracic
radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1
and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.

- Consolidation chemotherapy (courses 5-8): Beginning 3-5 weeks after completion of
chemoradiotherapy, all patients receive consolidation chemotherapy comprising
pemetrexed disodium alone IV over 10 minutes on day 1. Treatment repeats every 21 days
for 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 3 years.

PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this
study within 10-13 months.

Inclusion Criteria


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

- Squamous cell carcinoma

- Adenocarcinoma (including bronchoalveolar cell carcinoma)

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

- Stage IIIA OR selected stage IIIB disease*

- Any T, N2-3, M0 disease

- T3, N1-3, M0 disease allowed provided disease is unresectable

- T4, any N, M0 disease allowed provided T4 status cannot be determined due to
malignant effusion

- No T3, N0, M0 disease NOTE: *If the largest mediastinal lymph node is < 2 cm in
diameter by CT scan, a biopsy confirmation of mediastinal nodal involvement is

- Unresectable disease

- Contralateral mediastinal disease (N3) allowed provided all gross disease can be
encompassed within the radiation field in accordance with the homogeneity criteria

- Measurable disease, defined as ≥ 1 one-dimensional measurable lesion ≥ 20 mm by
conventional techniques OR ≥ 10 mm by spiral CT scan

- The following are not considered measurable disease:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural or pericardial effusion

- Abdominal masses not confirmed and followed by imaging techniques

- Cystic lesions

- Tumor lesions in a previously irradiated area

- No exudative, bloody, or cytologically positive malignant effusion

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

- Pleural effusion detectable by chest CT scan but not by chest x-ray that is too
small to tap

- New pleural effusion appearing after thoracotomy or other invasive thoracic
procedure allowed

- No atelectasis of the entire lung

- No direct invasion of the vertebral body

- No scalene, supraclavicular, or contralateral hilar node involvement

- No distant metastases (M1) by fludeoxyglucose F18 positron emission tomography



- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- Not specified


- Granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3


- Bilirubin < 1.5 times upper limit of normal (ULN)

- AST and ALT < 3 times ULN

- Alkaline phosphatase < 3 times ULN


- Creatinine clearance ≥ 45 mL/min


- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia


- Not pregnant or nursing

- Weight loss ≤ 10% within the past 3 months

- No other active* malignancy except nonmelanoma skin cancer

- No ongoing or active infection

- No other uncontrolled illness

- No history of hypersensitivity to carboplatin, pemetrexed disodium, or a monoclonal
antibody NOTE: *Malignancy is not considered active if the patient has completed
treatment and has < 30% risk of relapse


Biologic therapy

- No concurrent filgrastim (G-CSF), pegfilgrastim, or sargramostim (GM-CSF) during
thoracic radiotherapy or as prophylaxis for myelosuppression


- No prior chemotherapy for NSCLC

- No other concurrent chemotherapy

Endocrine therapy

- No concurrent hormonal therapy except megestrol for appetite stimulation or
dexamethasone to prevent rash from pemetrexed disodium


- No prior radiotherapy to the chest

- No concurrent palliative radiotherapy

- No concurrent intensity modulated radiotherapy


- See Disease Characteristics

- At least 2 weeks since prior formal exploratory thoracotomy


- No prior therapy that directly targets the epidermal growth factor receptor pathway

- No concurrent combination antiretroviral therapy for HIV-positive patients

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

18 Month Survival

Outcome Description:

Percentage of participants who were alive at 18 months. The 18 month survival, with 95% CI, was estimated using the Kaplan-Meier method.

Outcome Time Frame:

18 months (from randomization)

Safety Issue:


Principal Investigator

Ramaswamy Govindan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Washington University Siteman Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

September 2005

Completion Date:

September 2012

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



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