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Phase II Study as First Line Treatment for Patients With Advanced Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Carcinoma, Non-Small-Cell Lung

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Trial Information

Phase II Study as First Line Treatment for Patients With Advanced Non-Small Cell Lung Cancer

This research study is being done to determine if cetuximab will improve efficacy of
standard chemotherapy. This agent targets epidermal growth factor receptor (EGFR). EGFR
sits on the outside of tumor cells and controls tumor cell growth. This agent has been
looked at alone and with other chemotherapy drugs in non-small-cell lung cancer (NSCLC). It
has shown to be safe and can shrink tumors. There is little information about the
combination of this agent with both paclitaxel and carboplatin. This study combines
cetuximab with monthly carboplatin and weekly paclitaxel.

Inclusion Criteria:

- Histologically or cytologically documented stage IIIB or IV NSCLC

- Measurable disease

- ECOG performance status of 0-1

- Asymptomatic brain metastasis; must have completed radiotherapy/radiosurgery at least
2 weeks prior to enrollment and be off steroids.

- Radiotherapy must have been completed > 2 weeks prior to enrollment and patients must
have recovered from adverse events of radiotherapy.

- >/= 18 years of age

- Adequate hematologic function: absolute neutrophil count (ANC) >/= 1,500/mm3;
platelets >/= 100,000/mm3.

- Adequate hepatic function: total bilirubin and ALT
- Adequate renal function: serum creatinine /=
50cc/minute if serum creatinine > 1.5

- Signed an approved informed consent for this protocol and an approved informed
consent for Health Insurance Portability and Accountability Act (HIPAA)

- EGFR status by immunohistochemistry (IHC) if sufficient tissue is available

Exclusion Criteria:

- Women of childbearing potential who have a positive pregnancy test at enrollment or
within 7 days of treatment. In addition, men enrolled on this study should
understand the risks to any sexual partner of childbearing potential and should
practice an effective method of birth regulation/control. Note: Patients are
considered to not be of childbearing potential if they are surgically sterile (they
have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy)
or they are postmenopausal.

- Patients who have had prior malignancy, except for adequately treated basal cell or
squamous cell skin cancer, in situ cervical cancer, or other cancer for which the
patient has been disease-free for 3 years.

- Patients with significant history of cardiac disease, i.e., uncontrolled
hypertension, unstable angina, uncontrolled congestive heart failure, myocardial
infarction within the past year, cardiomyopathy with decreased ejection fraction, or
cardiac ventricular arrythmias within the last year requiring new treatment .

- Patients with an uncontrolled seizure disorder, or active neurological disease.

- Patients with symptomatic brain metastasis.

- Patients who have received prior systemic chemotherapy.

- Patients who have received prior cetuximab or other therapy which specifically and
directly targets the EGF pathway.

- Prior infusion reaction to a monoclonal antibody or prior hypersensitivity to
Cremophor EL.

- Patients with known peripheral neuropathy (> grade 1).

Type of Study:


Study Design:

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

Outcome Measure:

To determine the response rate and stable disease rate with this combination regimen

Principal Investigator

Corey Langer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

December 2004

Completion Date:

June 2008

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Advanced Non-small Cell Lung Cancer
  • First Line Treatment
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Consultants in Medical Oncology & Hematology Inc.Drexel Hill, Pennsylvania  19026