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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

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

DISEASE CHARACTERISTICS:

- 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
required

- 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

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- Not specified

Hematopoietic

- Granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

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

- AST and ALT < 3 times ULN

- Alkaline phosphatase < 3 times ULN

Renal

- Creatinine clearance ≥ 45 mL/min

Cardiovascular

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

Other

- 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

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

Chemotherapy

- 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

Radiotherapy

- No prior radiotherapy to the chest

- No concurrent palliative radiotherapy

- No concurrent intensity modulated radiotherapy

Surgery

- See Disease Characteristics

- At least 2 weeks since prior formal exploratory thoracotomy

Other

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

- No concurrent combination antiretroviral therapy for HIV-positive patients

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

Investigator Name:

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

Other Information

Sponsor: Cancer and Leukemia Group B
Phase: Phase 2
Trial ID: NCT00117962
Volunteers:  Not Accepting Healthy Volunteers

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