NCT00082212

Brief Summary

The purpose of this study is to determine the overall response rate, time to progression, and 1 yr survival with cetuximab in patients with ovarian or primary peritoneal carcinoma.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_2 ovarian-cancer

Timeline
Completed

Started Nov 2004

Geographic Reach
1 country

5 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

May 3, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2004

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2004

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

April 9, 2010

Status Verified

April 1, 2010

Enrollment Period

2.6 years

First QC Date

May 3, 2004

Last Update Submit

April 8, 2010

Conditions

Ovarian Cancer

Keywords

ovarianprimary peritoneal cancerPersistent or Recurrent Ovarian CancerPrimary Peritoneal Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Overall response rate

    Every six weeks

Secondary Outcomes (1)

  • Relationship between response, dose, and occurence of rash

    Every six weeks

Study Arms (1)

1

EXPERIMENTAL

400 mg/m2 loading dose, 250 mg/m2 weekly X 2 Cycles

Biological: Cetuximab

Interventions

CetuximabBIOLOGICAL

400 mg/m2 loading dose, 250 mg/m2 weekly X 2 Cycles

Also known as: Erbitux
1

Eligibility Criteria

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

You may qualify if:

  • subjects must have recurrent or persistent epithelial ovarian or primary peritoneal carcinoma. Histologic confirmation of the original primary tumor is required.
  • EGFR expression must be positive as determined by an outside reference lab
  • Subjects must have had a treatment-free interval following platinum of \<12 mos
  • All subjects must have measurable disease at baseline
  • Subjects must have at least one recurrent lesion to be used to assess response
  • Recovery from effect of recent surgery, radiotherapy or chemotherapy

You may not qualify if:

  • Subjects with other invasive malignancies (including peritoneal mesotheliomas)
  • Subjects with unstable cardiac disease or MI within 6 mos
  • Subjects with Acute hepatitis
  • Subjects with active or uncontrolled infection
  • A history of prior cetuximab or other therapy which targets the EGFR pathway or prior history of prior chimerized or murine monoclonal antibody therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

ImClone Investigational Site

Birmingham, Alabama, 35233, United States

Location

ImClone Investigational Site

Orlando, Florida, 32804, United States

Location

ImClone Investigational Site

New York, New York, 10021, United States

Location

ImClone Investigational Site

Philadelphia, Pennsylvania, 19111, United States

Location

ImClone Investigational Site

Seattle, Washington, 09104, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

  • E-mail: ClinicalTrials@ ImClone.com

    Eli Lilly and Company

    STUDY CHAIR

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

May 3, 2004

First Posted

May 5, 2004

Study Start

November 1, 2004

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

April 9, 2010

Record last verified: 2010-04

Locations

US(5)