Cetuximab and Vinorelbine in Elderly Subjects With Lung Cancer - Full Text View

Purpose

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.

Condition	Intervention	Phase
Non-small Cell Lung Cancer	Drug: Cetuximab Drug: Vinorelbine (Navelbine)	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Trial of Cetuximab Plus Vinorelbine in Previously Untreated Patients > 70 With Advanced NSCLC

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Vinorelbine Vinorelbine tartrate Cetuximab

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Estimated Enrollment:	53
Study Start Date:	June 2005
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	70 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165334

Locations

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

Sponsors and Collaborators

Dana-Farber Cancer Institute

Massachusetts General Hospital

Brigham and Women's Hospital

Beth Israel Deaconess Medical Center

Bristol-Myers Squibb

Investigators

Principal Investigator:

Pasi A Janne, MD, PhD

Dana-Farber Cancer Institute

More Information

Publications:

Gridelli C, Perrone F, Gallo C, Cigolari S, Rossi A, Piantedosi F, Barbera S, Ferrau F, Piazza E, Rosetti F, Clerici M, Bertetto O, Robbiati SF, Frontini L, Sacco C, Castiglione F, Favaretto A, Novello S, Migliorino MR, Gasparini G, Galetta D, Iaffaioli RV, Gebbia V; MILES Investigators. Chemotherapy for elderly patients with advanced non-small-cell lung cancer: the Multicenter Italian Lung Cancer in the Elderly Study (MILES) phase III randomized trial. J Natl Cancer Inst. 2003 Mar 5;95(5):362-72.

[No authors listed] Effects of vinorelbine on quality of life and survival of elderly patients with advanced non-small-cell lung cancer. The Elderly Lung Cancer Vinorelbine Italian Study Group. J Natl Cancer Inst. 1999 Jan 6;91(1):66-72.

ClinicalTrials.gov Identifier:	NCT00165334 History of Changes
Other Study ID Numbers:	04-422
Study First Received:	September 9, 2005
Last Updated:	July 21, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

Non-small cell lung cancer
Cetuximab
Vinorelbine
Navelbine
Previously untreated lung cancer

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms

Lung Diseases
Respiratory Tract Diseases
Vinorelbine
Cetuximab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013