NCT00162110

Brief Summary

This is a Phase II open-label trial evaluating the efficacy, and safety of Erbitux in patients with mucinous gastrointestinal adenocarcinoma involving the peritoneal surface.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2004

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

October 28, 2015

Status Verified

October 1, 2015

Enrollment Period

2.2 years

First QC Date

September 9, 2005

Last Update Submit

October 26, 2015

Conditions

Mucinous Gastrointestinal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Evaluate the efficacy of Erbitux in the treatment of mucinous gastrointestinal adenocarcinoma involving the peritoneal surfaces based on clinical response rate.

Secondary Outcomes (1)

  • To evaulate surgically resected tumor specimens of the EGF receptor, mucins 1-6, and anglogenic indices such as vessel counts, VEGF expression, and Ki-67 expression. To evaluate the safety of Erbitux monotherapy in this patient population.

Study Arms (1)

1

ACTIVE COMPARATOR
Drug: cetuximab

Interventions

cetuximabDRUG

mg, IV, 225 mg/m2, weekly, 4-52 weeks depending on response.

Also known as: Erbitux
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to take care of self. Out of bed less than 50% of the day
  • Absolute neutrophil count \>=1,500
  • Platelet count \>=100,000
  • Total bilirubin count \<=1.5 times the upper limit of normal

You may not qualify if:

  • Prior epidermal growth factor receptor antibody
  • Prior treatment with Erbitux
  • Other cancers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Local Institution

New York, New York, United States

Location

Local Institution

Cincinnati, Ohio, United States

Location

MeSH Terms

Interventions

Cetuximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 13, 2005

Study Start

November 1, 2004

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

October 28, 2015

Record last verified: 2015-10

Locations

US(2)