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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
ImClone LLC
ClinicalTrials.gov Identifier:
NCT00063388
First received: June 25, 2003
Last updated: April 8, 2010
Last verified: April 2010
  Purpose

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


Condition Intervention Phase
Non-Small-Cell Lung Cancer
Biological: Cetuximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Cetuximab (C225) as Therapy for Recurrent Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by ImClone LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine the tumor response rate in the total population and in EGFR- subjects [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
  • Time to disease progression in the EGFR+ and total populations. [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
  • Survival in the EGFR+ and total populations. [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
  • Safety in the EGFR+ and total populations. [ Time Frame: Every 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 66
Study Start Date: May 2003
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Chief Medical Officer, ImClone LLC
ClinicalTrials.gov Identifier: NCT00063388     History of Changes
Other Study ID Numbers: CA225-012
Study First Received: June 25, 2003
Last Updated: April 8, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by ImClone LLC:
Non
Small
Cell
Lung
Cancer

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

ClinicalTrials.gov processed this record on October 22, 2014