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

Tracking Information

First Received Date ^ICMJE

June 25, 2003

Last Updated Date

December 14, 2009

Start Date ^ICMJE

May 2003

Primary Completion Date

June 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00063388 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Non-Randomized
Control:  Uncontrolled
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Open Label
Primary Purpose:  Treatment

Condition ^ICMJE

Non-Small-Cell Lung Cancer

Intervention ^ICMJE

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

Study Arms / Comparison Groups

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).

Intervention: Biological: Cetuximab

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2005

Primary Completion Date

June 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00063388

Responsible Party

Chief Medical Officer, ImClone LLC

Study ID Numbers ^ICMJE

CA225-012

Study Sponsor ^ICMJE

ImClone LLC

Collaborators ^ICMJE

Bristol-Myers Squibb

Investigators ^ICMJE

Principal Investigator:

Nasser Hanna, MD

Indiana Cancer Pavilion

Information Provided By

ImClone LLC

Verification Date

December 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP