NCT00165334

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_2 nonsmall-cell-lung-cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

July 22, 2009

Status Verified

July 1, 2009

Enrollment Period

2.4 years

First QC Date

September 9, 2005

Last Update Submit

July 21, 2009

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small cell lung cancerCetuximabVinorelbineNavelbinePreviously untreated lung cancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • 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.

Interventions

CetuximabDRUG
Vinorelbine (Navelbine)DRUG

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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
  • or more weeks since completing prior radiotherapy
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

  • 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. doi: 10.1093/jnci/95.5.362.

    PMID: 12618501BACKGROUND

  • 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. doi: 10.1093/jnci/91.1.66.

    PMID: 9890172BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

CetuximabVinorelbine

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Pasi A Janne, MD, PhD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

June 1, 2005

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

July 22, 2009

Record last verified: 2009-07

Locations

US(3)