Cetuximab and Vinorelbine in Elderly Subjects With Lung Cancer

This study has been completed.
Sponsor:
Collaborators:
Massachusetts General Hospital
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Bristol-Myers Squibb
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00165334
First received: September 9, 2005
Last updated: July 21, 2009
Last verified: July 2009

September 9, 2005
July 21, 2009
June 2005
November 2007   (final data collection date for primary outcome measure)
To determine the overall response of cetuximab plus vinorelbine in patients 70 years or older with non-small lung cancer.
- To determine the overall response of cetuximab plus vinorelbine in patients 70 years or older with non-small lung cancer.
Complete list of historical versions of study NCT00165334 on ClinicalTrials.gov Archive Site
  • To determine the safety of cetuximab plus vinorelbine in patients 70 years or older
  • to determine the time to progression and survival rates of patients treated with cetuximab plus vinorelbine.
  • - To determine the safety of cetuximab plus vinorelbine in patients 70 years or older
  • - To determine the time to progression and survival rates of patients treated with cetuximab plus vinorelbine.
Not Provided
Not Provided
 
Cetuximab and Vinorelbine in Elderly Subjects With Lung Cancer
Phase II Trial of Cetuximab Plus Vinorelbine in Previously Untreated Patients > 70 With Advanced NSCLC

The purpose of this study is it to determine how well patients with non-small cell lung cancer respond to cetuximab plus vinorelbine. We would also like to determine the safety of cetuximab plus vinorelbine in people 70 years of age or older with advanced non-small cell lung cancer.

  • 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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-small Cell Lung Cancer
  • Drug: Cetuximab
  • Drug: Vinorelbine (Navelbine)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
November 2007
November 2007   (final data collection date for primary outcome measure)

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
Both
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00165334
04-422
Not Provided
Not Provided
Dana-Farber Cancer Institute
  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Beth Israel Deaconess Medical Center
  • Bristol-Myers Squibb
Principal Investigator: Pasi A Janne, MD, PhD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP