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Safety and Efficacy (Phase II) Study of Concurrent Cetuximab Plus Conformal Thoracic Radiotherapy in (Poor Prognosis) Patients With Inoperable or Unresectable, Locally Advanced Non-Small Cell Lung Cancer (LA - NSCLC)

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

Safety and Efficacy (Phase II) Study of Concurrent Cetuximab Plus Conformal Thoracic Radiotherapy in (Poor Prognosis) Patients With Inoperable or Unresectable, Locally Advanced Non-Small Cell Lung Cancer (LA - NSCLC)

Patients will be asked to spend about six months in this study. There will be 4 different
phases in this study as follows: (1) Loading Phase: This is the first week (week 1) of the
study, when patients receive their first (loading) dose of cetuximab only, in the vein. (2)
Concurrent Phase: During this phase patients will be treated simultaneously (concurrently)
with radiation therapy to their chest and cetuximab. Radiation is delivered 5 days a week,
Monday to Friday for a total of 7 weeks (weeks 2-8). Cetuximab is delivered in the vein,
weekly, during the weeks of radiation. (3) Recovery Phase: Patients receive no treatment
during these next 3 weeks (weeks 9-11). This phase is designed to allow patients to recover
from side effects before they start the last phase. (4) Consolidation Phase: The last phase.
Patients will receive 3 doses of chemotherapy with docetaxel during this phase. Docetaxel is
given intravenously every 21 days. Patients also receive weekly cetuximab during this phase.
Cetuximab is delivered in a similar way as it was during the concurrent (second) phase of
this study. In total, this phase lasts 6 weeks (weeks 12-18). Once the therapy treatment is
completed, and if the patient's cancer did not get worse, follow up visits will include
visits to their physician every three months for 2 years, then every 4 months for 2 years or
more, as long as their cancer doesn't get worse (at which time they will be removed from the

Inclusion Criteria:

- Histologically or cytologically confirmed inoperable or unresectable, LA-NSCLC
(adenocarcinoma, squamous cell carcinoma or anaplastic large cell carcinoma or
non-small cell otherwise not specified).

- Eligible Stages: Stages IIA through IIIA disease if it is felt that they are not
candidates for possible resection, medically or otherwise. Stage IIIA (multi-station
mediastinal lymph nodes) and stage IIIB disease without significant pleural effusion
(metastases to contralateral mediastinal or supraclavicular lymph nodes) are also

- Age ≥ 70 OR Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 2 at
time of registration OR weight loss ≥ 5% in the preceding three months to the time of

- Must have measurable disease by the Response Evaluation Criteria in Solid Tumors
(RECIST) criteria. When applicable, baseline measurements/evaluations must be
obtained within 4 weeks prior to registration.

- Must have adequate bone marrow reserve as determined by the following laboratory
values, obtained within 14 days prior to registration:

- White blood cell count (WBC) ≥ 4000/ul or absolute neutrophil count (ANC) ≥

- Platelet count ≥ 100,000/ul

- Hemoglobin ≥ 8 gms/dl

- Adequate renal and liver function as determined by the following laboratory values,
obtained within 14 days prior to registration:

- Serum creatinine ≤ 2.0 mg/dl or creatinine clearance ≥ 40 cc/min

- Bilirubin < 2.0 mg/dl

- serum glutamic oxaloacetic transaminase (SGOT) ≤ 2.5 times the upper limit of

- Written, informed consent must be obtained prior to registration

- Women of childbearing potential (WOCBP) must use an accepted, effective method of
contraception during the course of the study, in a manner such that risk of failure
is minimized. Sexually active males enrolled should understand the risks to any
sexual partner of childbearing potential; must also practice an effective method of
contraception. WOCBP must be advised of the importance of avoiding pregnancy during
trial participation and the potential risk factors for an unintentional pregnancy;
have a negative pregnancy test within 7 days prior to first receiving investigational
product; be instructed to contact the Investigator immediately if they suspect they
might be pregnant at any time during study participation. Investigator must
immediately notify Bristol-Myers Squibb (BMS) in the event of a confirmed pregnancy
in a patient participating in the study. If the pregnancy test is positive, the
patient must not receive investigational product and must not be enrolled in the

Exclusion Criteria:

- Must not have small cell carcinoma as part of the histological specimen

- Evidence of distant metastasis.

- History of a prior or concomitant malignancy in the past 3 years except for
surgically cured basal cell carcinoma of the skin or carcinoma in situ of the cervix.
Invasive malignancies, properly treated and currently disease-free > 3 years are

- Prior thoracic radiotherapy or epidermal growth factor receptor (EGFR) pathway
targeting therapy. Prior systemic chemotherapy is allowed if received as therapy for
an invasive malignancy, currently disease-free > 3 years

- Concomitant life threatening or uncontrolled serious medical illness such as cardiac
disease (uncontrolled hypertension, arrhythmia, unstable angina, recent myocardial
infarction, end stage congestive heart failure, cardiomyopathy with decreased
ejection fraction), liver disease with significant hepatic insufficiency, kidney
disease with significant renal insufficiency or organic brain syndrome.

Type of Study:


Study Design:

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

Outcome Measure:

Number of Participants With Progression Free Survival

Outcome Description:

Determine the progression free survival (PFS) of concurrent cetuximab plus conformal thoracic radiotherapy (CTRT) and consolidation docetaxel plus cetuximab, in newly diagnosed patients with inoperable or unresectable, LA-NSCLC and poor prognostic characteristics.

Outcome Time Frame:

11 Weeks

Safety Issue:


Principal Investigator

Alberto Chiappori, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

April 2008

Completion Date:

December 2013

Related Keywords:

  • Lung Cancer
  • Lung
  • Thoracic
  • Immunotherapy
  • Radiotherapy
  • LA - NSCLC
  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612