Phase II Study in Patients With Recurrent Non-Small-Cell Lung Cancer

April 8, 2010 updated by: Eli Lilly and Company

A Phase II Trial of Cetuximab (C225) as Therapy for Recurrent Non-Small Cell Lung Cancer (NSCLC)

Determine tumor response rate and time to disease progression, survival and safety in total populations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To determine the tumor response rate and time to disease progression, survival and safety in the EGFR-positive, EGFR-negative and total populations.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Aventura, Florida, United States, 33180
        • ImClone Investigational Site
      • Miami Beach, Florida, United States, 33140
        • ImClone Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • ImClone Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • ImClone Investigational Site
      • South Bend, Indiana, United States, 46601
        • ImClone Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • ImClone Investigational Site
      • Boston, Massachusetts, United States, 02115
        • ImClone Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • ImClone Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  1. Subjects with recurrent or progressive NSCLC with either present or prior histologic confirmation or pathologic confirmation of NSCLC
  2. Subjects receiving 1 or more prior chemotherapy regimens for the treatment of recurrent/metastatic disease, including at least 1 platinum-based combination
  3. Unidimensionally measurable NSCLC
  4. Subjects with tumor tissue available for EGFR assessment
  5. ECOG performance status of 0 or 1
  6. Subjects with asymptomatic brain metastasis were eligible; however, they must have completed radiotherapy/radiosurgery at least 3 weeks prior to enrollment and have been off steroids

Exclusion Criteria

  1. Women of childbearing potential who were unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study. Male subjects must also have agreed to use effective contraception
  2. Women of childbearing potential using a prohibited contraceptive method
  3. Women who were pregnant or breastfeeding
  4. Women with a positive pregnancy test on enrollment or prior to study drug administration.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Cetuximab 400 mg/m2 intravenously (IV) (over 120 minutes) on Day 1 of Cycle 1. followed by weekly doses of 250 mg/m2 (over 60 minutes).
Biological: Cetuximab
Cetuximab 400 mg/m2 intravenously (IV) (over 120 minutes) on Day 1 of Cycle 1. followed by weekly doses of 250 mg/m2 (over 60 minutes).
Other Names:
  • Erbitux

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary objective of this study was to determine the tumor response rate for single-agent cetuximab in EGFR+ subjects.
Time Frame: Every 8 weeks
Every 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine the tumor response rate in the total population and in EGFR- subjects
Time Frame: Every 8 weeks
Every 8 weeks
Time to disease progression in the EGFR+ and total populations.
Time Frame: Every 8 weeks
Every 8 weeks
Survival in the EGFR+ and total populations.
Time Frame: Every 8 weeks
Every 8 weeks
Safety in the EGFR+ and total populations.
Time Frame: Every 8 weeks
Every 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Collaborators

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

June 25, 2003

First Submitted That Met QC Criteria

June 26, 2003

First Posted (Estimate)

June 27, 2003

Study Record Updates

Last Update Posted (Estimate)

April 12, 2010

Last Update Submitted That Met QC Criteria

April 8, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA225-012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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