Clinical trial NCT00063388: Phase II Study in Patients With Recurrent Non-Small-Cell Lung Cancer
Official title: A Phase II Trial of Cetuximab (C225) as Therapy for Recurrent Non-Small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small-Cell Lung Cancer
Keywords: Non
Small
Cell
Lung
Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2003-06-27
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: The primary objective of this study was to determine the tumor response rate for single-agent cetuximab in EGFR+ subjects.
timeFrame: Every 8 weeks
Secondary outcomes:
measure: Determine the tumor response rate in the total population and in EGFR- subjects
timeFrame: Every 8 weeks
measure: Time to disease progression in the EGFR+ and total populations.
timeFrame: Every 8 weeks
measure: Survival in the EGFR+ and total populations.
timeFrame: Every 8 weeks
measure: Safety in the EGFR+ and total populations.
timeFrame: Every 8 weeks
Other outcomes:
Locations:
city: Aventura
country: United States
facility: ImClone Investigational Site
state: Florida
city: Miami Beach
country: United States
facility: ImClone Investigational Site
state: Florida
city: Chicago
country: United States
facility: ImClone Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: ImClone Investigational Site
state: Indiana
city: South Bend
country: United States
facility: ImClone Investigational Site
state: Indiana
city: Boston
country: United States
facility: ImClone Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: ImClone Investigational Site
state: Massachusetts
city: Saint Louis
country: United States
facility: ImClone Investigational Site
state: Missouri
Study officials:
affiliation: Eli Lilly and Company
name: E-mail: ClinicalTrials@ ImClone.com
role: STUDY_CHAIR
References: