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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

Phase 1
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

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



- Test the feasibility and toxicity of combined cetuximab, weekly docetaxel, and
concurrent radiotherapy in patients with poor-risk stage III non-small cell lung cancer


- Evaluate response rates (confirmed and unconfirmed, complete and partial) as well as
overall and progression-free survival.

- Correlate EGFR mutations, KRAS mutations, EGFR/HER2 gene copy number detected by FISH,
and protein expression by immunohistochemistry of EGFR-HER signaling pathways,
phosphorylation, proliferative markers, apoptotic markers, selected oncogene markers,
and markers for angiogenesis in biopsied pre-treatment tumor tissues with response and
survival outcomes.

- Explore possible associations between changes in plasma angiogenic factors (VEGF, IL-8,
bFGF) and cytokine levels (IL-6, IL-1α, ICAM, TGF-β, and others) and the risk of
treatment-related pneumonitis and esophagitis.

OUTLINE: Patients are enrolled sequentially to 1 of 2 treatment groups.

- Cohort 1: Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22.

- Cohort 2: Patients receive cetuximab as in group 1 followed by docetaxel IV over 15-30
minutes on days 8, 15, and 22 of course 1 and on days 1, 8, 15, and 22 of course 2.

Initially, 27 patients will be enrolled in Cohort 1. Once all patients in Cohort 1 have
discontinued treatment, if toxicity rates are acceptable per protocol specifications, an
additional 27 patients will be enrolled to Cohort 2. Treatment in both cohorts repeats every
28 days for 2 courses in the absence of disease progression or unacceptable toxicity. All
patients also undergo radiotherapy once daily, 5 days a week, beginning on day 8 of course 1
and continuing through course 2 (approximately 7 weeks). Patients with no progressive
disease then receive cetuximab alone once weekly. Treatment with cetuximab alone continues
in the absence of disease progression for up to 2 years.

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

PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.

Inclusion Criteria


- 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


- 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


- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Treatment-related Esophagitis or Pneumonitis

Outcome Description:

The primary endpoint will be the rate of Grade 3 or greater esophagitis and/or pneumonitis within 4 months after discontinuation of radiation therapy.

Outcome Time Frame:

Weekly for the first 8 weeks, then every 4 weeks thereafter for up to 4 months after complettion of radiotherapy.

Safety Issue:


Principal Investigator

Yuhchyau Chen, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

James P. Wilmot Cancer Center


United States: Federal Government

Study ID:




Start Date:

April 2006

Completion Date:

April 2012

Related Keywords:

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



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