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A Pilot (Phase I) Study of Weekly Docetaxel and Cetuximab Chemoradiation for Poor Risk Stage III Non-Small Cell Lung Cancer

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

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving docetaxel and cetuximab together with radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when given together with cetuximab and radiation therapy in treating patients with stage III non-small cell lung cancer.

Date & Status

Terminated

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

DISEASE CHARACTERISTICS:

- Histologically or cytologically proven newly diagnosed single, primary, bronchogenic
stage IIIA or selected stage IIIB (excluding malignant pleural effusion) non-small
cell lung cancer (NSCLC) of one of the following cellular types:

- Adenocarcinoma

- Large cell carcinoma

- Squamous cell carcinoma

- Unspecified

- Histology or cytology from involved mediastinal or supraclavicular nodes will be
sufficient for diagnosis if a separate primary lesion of the lung parenchyma is
clearly evident on radiographs (i.e., a second biopsy will not be required)

- Underwent positron emission tomography (PET) scan within the past 42 days

- N2 or N3 mediastinal disease by PET scan OR enlarged nodes on CT scan determined
to be N2 or N3 by biopsy

- Measurable disease, defined as lesions that can be accurately measured in at least
one dimension as ≥ 2 cm by conventional techniques or ≥ 1 cm by spiral CT scan

- Pleural effusion, ascites, bone lesions, and laboratory parameters are not
considered measurable disease

- No brain metastases

- Malignant pleural effusion allowed provided 1 of the following is true:

- Present before mediastinoscopy or exploratory thoracotomy AND the pleural fluid
is transudate with negative cytology

- Present only after but not before exploratory or staging thoracotomy AND the
pleural fluid is either transudate or exudate with negative cytology

- Present only on CT scan but not on decubitus chest x-ray AND deemed too small to
tap under either CT scan or ultrasound guidance

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-1, meeting ≥ 1 of the following criteria OR Zubrod
performance status 2 with no co-morbidities or meeting 1 of the following criteria:

- No co-morbidities

- FEV_1 < 2 L OR < 1 L with estimated contralateral FEV_1 ≥ 0.6 L

- DLCO > 10 mL/mm Hg/min

- Albumin < 0.85 times lower limit of normal

- Unintentional weight loss > 10% within the past 6 months

- Controlled congestive heart failure which, in the opinion of the investigator,
may become decompensated due to radiotherapy

- FEV_1 < 2 L OR < 1 L with estimated contralateral FEV_1 ≥ 0.6 L

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

- Platelet count ≥ 100,000/mm^3

- Serum creatinine ≤ 1.5 times upper limit of normal (ULN)

- Must provide prior smoking history

- Serum bilirubin normal

- Meets one of the following criteria:

- Alkaline phosphatase (AP) ≤ 4 times ULN AND SGOT or SGPT normal

- AP normal AND SGOT or SGPT ≤ 2.5 times ULN

- No other prior malignancy within the past 5 years except adequately treated basal
cell or squamous cell skin cancer, in situ cervical cancer, or adequately treated
stage I or II cancer from which the patient is currently in complete remission

- No pregnant or nursing patients

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy or curative surgery for this cancer

- No prior radiotherapy to the neck and/or thorax for any reason

- No prior therapy which specifically targets the EGFR pathway

- No concurrent growth factors (e.g., filgrastim [G-CSF], epoetin alfa, or
pegfilgrastim) or amifostine

- No concurrent intensity-modulated radiotherapy

- No concurrent prophylactic mediastinal, contralateral hilar, or supraclavicular lymph
node radiotherapy

Gender: Both
Steward Physician(s)
  • Yuhchyau Chen, MD, PhD
  • Kishan J. Pandya, MD
  • Derick H. Lau, MD
  • Karen Kelly, MD
  • Laurie E. Gaspar, MD, MBA
Facilities
  • St. Elizabeth's Medical Center - Terminated
Trial Interventions
Biological
  • cetuximab
Drug
  • docetaxel
Radiation
  • radiation therapy
Physician Researcher

Investigator Name:

  • Yuhchyau Chen, MD, PhD
  • Kishan J. Pandya, MD
  • Derick H. Lau, MD
  • Karen Kelly, MD
  • Laurie E. Gaspar, MD, MBA

Other Information

Sponsor: Southwest Oncology Group
Phase: Phase 1
Trial ID: NCT00288054
Volunteers:  Not Accepting Healthy Volunteers

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