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

Sponsors and Collaborators:	ImClone LLC Bristol-Myers Squibb
Information provided by:	ImClone LLC
ClinicalTrials.gov Identifier:	NCT00063388

Purpose

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

Condition	Intervention	Phase
Non-Small-Cell Lung Cancer	Drug: Cetuximab	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II Trial of Cetuximab (C225) as Therapy for Recurrent Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cetuximab

U.S. FDA Resources

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
1: Experimental 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).	Drug: 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).

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

Subjects with recurrent or progressive NSCLC with either present or prior histologic confirmation or pathologic confirmation of NSCLC
Subjects receiving 1 or more prior chemotherapy regimens for the treatment of recurrent/metastatic disease, including at least 1 platinum-based combination
Unidimensionally measurable NSCLC
Subjects with tumor tissue available for EGFR assessment
ECOG performance status of 0 or 1
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

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
Women of childbearing potential using a prohibited contraceptive method
Women who were pregnant or breastfeeding
Women with a positive pregnancy test on enrollment or prior to study drug administration.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063388

Locations

United States, Florida
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura, Florida, United States, 33180
United States, Illinois
Rush Presbyterian Hospital
Chicago, Illinois, United States, 60612
United States, Indiana
Michiana Hematology Oncology
South Bend, Indiana, United States, 46601
Indiana University Medical Center Indiana Cancer Pavilion,
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110

Sponsors and Collaborators

ImClone LLC

Bristol-Myers Squibb

Investigators

Principal Investigator:

Nasser Hanna, MD

Indiana Cancer Pavilion

More Information

No publications provided

Responsible Party:	ImClone Systems Incorporated ( Eric Rowinsky/ Chief Medical Officer )
Study ID Numbers:	CA225012
Study First Received:	June 25, 2003
Last Updated:	October 1, 2008
ClinicalTrials.gov Identifier:	NCT00063388 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by ImClone LLC:

Non
Small
Cell
Lung
Cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Cetuximab

Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Cetuximab
Pharmacologic Actions
Carcinoma
Neoplasms

Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 02, 2009