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

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ClinicalTrials.gov Identifier: NCT00063388
Recruitment Status : Completed
First Posted : June 27, 2003
Last Update Posted : April 12, 2010
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
ImClone LLC

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

Condition or disease Intervention/treatment Phase
Non-Small-Cell Lung Cancer Biological: Cetuximab Phase 2

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  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Cetuximab (C225) as Therapy for Recurrent Non-Small Cell Lung Cancer (NSCLC)
Study Start Date : May 2003
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Cetuximab
U.S. FDA Resources

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 Name: Erbitux



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Determine the tumor response rate in the total population and in EGFR- subjects [ Time Frame: Every 8 weeks ]
  2. Time to disease progression in the EGFR+ and total populations. [ Time Frame: Every 8 weeks ]
  3. Survival in the EGFR+ and total populations. [ Time Frame: Every 8 weeks ]
  4. Safety in the EGFR+ and total populations. [ Time Frame: Every 8 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00063388


Locations
United States, Florida
ImClone Investigational Site
Aventura, Florida, United States, 33180
ImClone Investigational Site
Miami Beach, Florida, United States, 33140
United States, Illinois
ImClone Investigational Site
Chicago, Illinois, United States, 60612
United States, Indiana
ImClone Investigational Site
Indianapolis, Indiana, United States, 46202
ImClone Investigational Site
South Bend, Indiana, United States, 46601
United States, Massachusetts
ImClone Investigational Site
Boston, Massachusetts, United States, 02114
ImClone Investigational Site
Boston, Massachusetts, United States, 02115
United States, Missouri
ImClone Investigational Site
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
ImClone LLC
Bristol-Myers Squibb
Investigators
Study Chair: E-mail: ClinicalTrials@ ImClone.com ImClone LLC

Responsible Party: Chief Medical Officer, ImClone LLC
ClinicalTrials.gov Identifier: NCT00063388     History of Changes
Other Study ID Numbers: CA225-012
First Posted: June 27, 2003    Key Record Dates
Last Update Posted: April 12, 2010
Last Verified: April 2010

Keywords provided by ImClone LLC:
Non
Small
Cell
Lung
Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Cetuximab
Antineoplastic Agents