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A Phase II Trial of Cetuximab (c225) as Therapy for Recurrent Non-Small Cell Lung Cancer in Patients Who Have Received Prior Therapy With Tyrosine Kinase Inhibitor Directed Against the EGFR Pathway


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer

Thank you

Trial Information

A Phase II Trial of Cetuximab (c225) as Therapy for Recurrent Non-Small Cell Lung Cancer in Patients Who Have Received Prior Therapy With Tyrosine Kinase Inhibitor Directed Against the EGFR Pathway


- Participants on this study will receive cetuximab by infusion intravenously once per
week and may continue to receive weekly cetuximab infusions until their disease
progresses or they experience unacceptable side effects.

- The following will be performed every 4 weeks while they are receiving study
treatments: Physical examination; performance status; and blood work. A CT scan of the
chest and upper abdomen will be performed every 8 weeks.


Inclusion Criteria:



- Pathologically confirmed stage IIIB or IV recurrent or progressive NSCLC

- Patients must have progressed while receiving treatment with a tyrosine kinase
inhibitor targeting the EGFR pathway

- Measurable disease, as defined by RECIST criteria

- Patients must have a suitable frozen or paraffin-embedded tissue sample available for
EGFR mutational analysis. Prior EGFR mutational analyses are allowable

- Patients with asymptomatic brain metastasis are eligible; however, they must have
completed radiotherapy/radiosurgery at least 3 weeks prior to enrollment and be
clinically stable

- ECOG Performance Status 0-2

- 18 years of age or older

- Negative pregnancy test within 7 days of treatment or be categorized as not of
child-bearing potential

- Bone marrow function, renal function, hepatic function as outlined in protocol

Exclusion Criteria:

- Women who are pregnant of breastfeeding

- Active concurrent malignancy

- Major thoracic or abdominal surgery within 30 days prior to the first infusion of
cetuximab

- Significant history of uncontrolled cardiac disease

- Uncontrolled seizure disorder, or active neurological disease

- Prior severe infusion reactions to a monoclonal antibody

- Prior chemotherapy regimen within 21 days prior to study entry

- Any EGFR tyrosine kinase inhibitor within 14 days of study entry

- Radiation therapy within 14 days prior to the first infusion of cetuximab

- Acute hepatitis or known HIV

- Active or uncontrolled infection

- Any concurrent chemotherapy or any other investigational agent(s)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate by CT Scan Using RECIST Criteria

Outcome Time Frame:

8 weeks

Safety Issue:

No

Principal Investigator

Lecia Sequist, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

06-026

NCT ID:

NCT00694603

Start Date:

September 2006

Completion Date:

September 2009

Related Keywords:

  • Non-Small Cell Lung Cancer
  • cetuximab
  • tyrosine kinase inhibitor
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617