Cetuximab Plus Conformal Thoracic Radiotherapy in Patients (Pts) With Inoperable or Unresectable Locally Advanced Non-Small Cell Lung Cancer (LA - NSCLC)

• Register: ClinicalTrials.gov
• Last refreshed on: 28 January 2013
• Main ID: NCT00673738
• Date of registration: 05/05/2008
• Primary sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Public title: Cetuximab Plus Conformal Thoracic Radiotherapy in Patients (Pts) With Inoperable or Unresectable Locally Advanced Non-Small Cell Lung Cancer (LA - NSCLC)
• Scientific title: 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)
• Date of first enrolment: April 2008
• Target sample size: 27
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00673738
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Alberto Chiappori, M.D.
• Affiliation: H. Lee Moffitt Cancer Center and Research Institute

Key inclusion & exclusion criteria

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
eligible.

- 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
registration

- 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) =
1000/ul

- 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
normal(ULN)

- 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
study.

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
allowed.

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Lung Cancer

Intervention(s)

Drug: Cetuximab

Radiation: Radiation Therapy

Primary Outcome(s)

Number of Participants With Progression Free Survival [Time Frame: 11 Weeks]

Secondary Outcome(s)

Best Overall Response [Time Frame: Dependent Upon Outcome]

Secondary ID(s)

106296

CA225286

MCC-15294

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bristol-Myers Squibb