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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

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Trial Conditions
  • Lung Cancer
What is the purpose of this trial?

RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, 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 kill tumor cells. 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 make tumor cells more sensitive to radiation therapy. Giving pemetrexed disodium, carboplatin, and radiation therapy together with cetuximab may kill more tumor cells. PURPOSE: This randomized phase II trial is studying how well giving pemetrexed disodium and carboplatin together with radiation therapy with or without cetuximab works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.

Date & Status


Who can Participate?


18 and older



1. Histologically or cytologically documented NSCLC, including squamous cell carcinoma,
adenocarcinoma including bronchoalveolar cell, and large cell anaplastic carcinoma
(including giant and clear cell carcinomas)

2. Eligible Disease Stages: Inoperable IIIA and Selected IIIB - Patients entered must be
considered unresectable or inoperable. Patients do not need to have a

A size of 2 cm or greater by CT is a sufficient criterion for the diagnosis of
mediastinal lymph node (N2 or N3) involvement by malignancy. If the largest
mediastinal lymph node is less than 2 cm in diameter, a biopsy confirmation of
mediastinal nodal involvement is required.

1. The following patients are eligible:

- Patients must be M0

- Patients with any T with N2 or N3 are eligible

- Patients with T3, N1-N3 disease are eligible if deemed unresectable

- Patients with T4, any N are eligible provided the T4 status is not
determined because of malignant effusion

- Patients with contralateral mediastinal disease (N3) are eligible if all
gross disease can be encompassed in the radiation field in accordance with
the homogeneity criteria

- Patients with a pleural effusion, which is a transudate, cytologically
negative and non-bloody, are eligible if the radiation oncologist feels the
tumor can be encompassed within a reasonable field of radiotherapy

- If a pleural effusion can be seen on the chest CT but not on CXR and is too
small to tap, the patient will be eligible. Patients who develop a new
pleural effusion after thoracotomy or other invasive thoracic procedure
will be eligible.

2. The following patients are NOT eligible:

- Patients with T3, N0 disease

- Patients with M1 disease

- Patients with atelectasis of the entire lung

- Patients with direct invasion of vertebral body

- Patients with scalene, supraclavicular, or contralateral hilar node

- Patients with exudative, bloody, or cytologically malignant effusions

3. Patients must have Measurable Disease: Lesions that can be accurately measured in at
least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional
techniques or as ≥10 mm with spiral CT scan. Lesions that are not considered
measurable include bone lesions, leptomeningeal disease, ascites, pleural/pericardial
effusion, abdominal masses that are not confirmed and followed by imaging techniques,
cystic lesions and tumor lesions situated in a previously irradiated area.

4. Prior Therapy: ≥ 2 weeks since formal exploratory thoracotomy. No prior chemotherapy
for NSCLC, chest radiation therapy or therapy that specifically and directly targets
the EGFR pathway

5. ECOG performance status 0-1

6. Positron Emission Tomography (PET) using 18 fluorodeoxyglucose (FDG) must be negative
for distant metastasis. PET imaging is mandatory.

7. Weight loss of ≤ 10% in the past 3 months

8. No "currently active" second malignancy other than non-melanoma skin cancers.
Patients are not considered to have a "currently active" malignancy if they have
completed therapy and are considered by their physician to be at less than 30% risk
of relapse.

9. Non-pregnant and non-nursing because of significant risk to the fetus/infant

10. Age ≥ 18 years

11. No patients with uncontrolled intercurrent illness including, but not limited to,
ongoing or active infection, symptomatic congestive heart failure, unstable angina
pectoris, cardiac arrhythmia, or psychiatric illness.

12. No HIV-positive patients receiving combination anti-retroviral therapy because
patients with immune deficiency are at increased risk of lethal infections when
treated with marrow-suppressive therapy

13. No known history of hypersensitivity to carboplatin, pemetrexed or a monoclonal

14. Required Initial Laboratory Values:

1. Granulocytes ≥ 1,500/mcl

2. Platelets ≥ 100,000/mcl

3. Calculated Creatinine Clearance ≥ 45 ml/min

4. Bilirubin < 1.5 x ULN

5. AST/ALT < 3 x ULN

6. Alkaline Phosphatase < 3 x ULN

Gender: Both
Steward Physician(s)
  • Ramaswamy Govindan, MD
  • Jeffrey A. Bogart, MD
  • Saint Anne's Hospital - Completed
Trial Interventions
  • cetuximab
  • carboplatin
  • pemetrexed disodium
  • radiation therapy
Physician Researcher

Investigator Name:

  • Ramaswamy Govindan, MD
  • Jeffrey A. Bogart, MD

Other Information

Sponsor: Alliance for Clinical Trials in Oncology
Phase: Phase 2
Trial ID: NCT00117962
Volunteers:  Not Accepting Healthy Volunteers

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