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

Non-Small-Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00063388
• Other study ID #: CA225-012
• Status: Completed
• Phase: Phase 2
• First received: June 25, 2003
• Last updated: April 8, 2010
• Start date: May 2003
• Est. completion date: June 2005

Study information

• Verified date: April 2010
• Source: ImClone LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small-Cell Lung Cancer

Intervention

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).

Locations

Country	Name	City	State
United States	ImClone Investigational Site	Aventura	Florida
United States	ImClone Investigational Site	Boston	Massachusetts
United States	ImClone Investigational Site	Boston	Massachusetts
United States	ImClone Investigational Site	Chicago	Illinois
United States	ImClone Investigational Site	Indianapolis	Indiana
United States	ImClone Investigational Site	Miami Beach	Florida
United States	ImClone Investigational Site	Saint Louis	Missouri
United States	ImClone Investigational Site	South Bend	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
ImClone LLC	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective of this study was to determine the tumor response rate for single-agent cetuximab in EGFR+ subjects.		Every 8 weeks	No
Secondary	Determine the tumor response rate in the total population and in EGFR- subjects		Every 8 weeks	No
Secondary	Time to disease progression in the EGFR+ and total populations.		Every 8 weeks	No
Secondary	Survival in the EGFR+ and total populations.		Every 8 weeks	No
Secondary	Safety in the EGFR+ and total populations.		Every 8 weeks	Yes