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A Study in Patients With Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

Primary Purpose

Ovarian Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cetuximab
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring ovarian, primary peritoneal cancer, Persistent or Recurrent Ovarian Cancer, Primary Peritoneal Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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

Outcomes

Primary Outcome Measures

Overall response rate

Secondary Outcome Measures

Relationship between response, dose, and occurence of rash

Full Information

First Posted
May 3, 2004
Last Updated
April 8, 2010
Sponsor
Eli Lilly and Company
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00082212
Brief Title
A Study in Patients With Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
Official Title
A Phase II Trial of Single-agent Cetuximab Dose Escalated to Rash in Patients With Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Terminated
Why Stopped
Due to lack of sufficient efficacy.
Study Start Date
November 2004 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
To determine the overall response rate of cetuximab alone in subjects with ovarian or primary peritoneal carcinoma who have persistent or recurrent disease following 1-2 previous regimens of chemotherapy. Potential relationship between response, dose, and the occurence of rash in the treatment of subjects who have stable disease after the initial 6 weeks of treatment, time to progression, and 1 yr survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
ovarian, primary peritoneal cancer, Persistent or Recurrent Ovarian Cancer, Primary Peritoneal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
400 mg/m2 loading dose, 250 mg/m2 weekly X 2 Cycles
Intervention Type
Biological
Intervention Name(s)
Cetuximab
Other Intervention Name(s)
Erbitux
Intervention Description
400 mg/m2 loading dose, 250 mg/m2 weekly X 2 Cycles
Primary Outcome Measure Information:
Title
Overall response rate
Time Frame
Every six weeks
Secondary Outcome Measure Information:
Title
Relationship between response, dose, and occurence of rash
Time Frame
Every six weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
E-mail: ClinicalTrials@ ImClone.com
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Chair
Facility Information:
Facility Name
ImClone Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
ImClone Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
ImClone Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
ImClone Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
ImClone Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
09104
Country
United States

12. IPD Sharing Statement

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A Study in Patients With Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

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