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Phase II Trial of Cetuximab Plus Vinorelbine in Previously Untreated Patients > 70 With Advanced NSCLC

Phase 2
70 Years
Not Enrolling
Non-small Cell Lung Cancer

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Trial Information

Phase II Trial of Cetuximab Plus Vinorelbine in Previously Untreated Patients > 70 With Advanced NSCLC

- Each cycle of study treatment is 21 days long. Cetuximab will be administered weekly
intravenously on days 1, 8 and 15 of the 21-day cycle.

- Vinorelbine will be administered intravenously on days 1 and 8 of the 21-day cycle. On
the days when the patient receives both cetuximab and vinorelbine, cetuximab will be
given first.

- For the first cycle only, the first infusion of cetuximab will be in a larger dose and
over a two-hour period of time. Beginning with the second treatment of cetuximab, the
patient will receive a smaller dose over a one-hour period of time.

- For the first treatment of cetuximab, the patient will have their blood pressure,
temperature, breathing rate and heart rate (vital signs) taken at the following time
points: before the infusion, 1/2 hour into the infusion, at the end of infusion, and
one hour after the infusion.

- For each subsequent cetuximab treatment, vital signs will be taken before each infusion
and one hour after the end of infusion. The patient will be required to remain in the
infusion room for one hour after the end of each cetuximab treatment for observation.

- CT scan(s), MRI(s), and/or x-rays(s) of the site(s) of cancer will be done every six
weeks (every two cycles) while the patient is on the study to assess the extent of the
cancer and the response to treatment.

- The duration of active participation in this study will depend on how the patients
non-small cell lung cancer responds to treatment and how well they tolerate the
treatment. The patient may receive up to six cycles of treatment with vinorelbine and
cetuximab. After these six cycles the patient may continue on cetuximab alone as long
as they are tolerating the drug and the cancer doesn't progress.

Inclusion Criteria:

- 70 years of age or greater

- Stage IV or IIIB Non-small cell lung cancer

- Must at least be able to walk and capable of taking care of yourself although unable
to carry out work activities

- 3 or more weeks since completing prior radiotherapy

- 3 or more weeks since prior major surgery

- Blood tests that show your kidneys, liver and bone marrow to be working adequately

- Life expectancy of 8 weeks or more

Exclusion Criteria:

- Prior anticancer therapy within the past 3 years, including chemotherapy

- Other currently active cancer

- Uncontrolled Central Nervous System (CNS) problems

- Pre-existing disease or abnormality of the nervous system

- Hepatitis or Known HIV

- Active uncontrolled infection

- Incomplete healing from previous major surgery

- Significant history of uncontrolled cardiac disease such as high blood pressure,
recent heart attack (within past 6 months), congestive heart failure, etc.

- Prior therapy which targets the ErbB pathway

- Prior severe infusion reaction to an antibody

- Chemotherapy or other investigational agent not indicated in the study protocol
occuring at the same time as this study treatment

- A medical condition that could make it unsafe for you to participate in this study

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:

To determine the overall response of cetuximab plus vinorelbine in patients 70 years or older with non-small lung cancer.

Principal Investigator

Pasi A Janne, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

June 2005

Completion Date:

November 2007

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non-small cell lung cancer
  • Cetuximab
  • Vinorelbine
  • Navelbine
  • Previously untreated lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617