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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00082212
• Other study ID #: CA225-046
• Status: Terminated
• Phase: Phase 2
• First received: May 3, 2004
• Last updated: April 8, 2010
• Start date: November 2004
• Est. completion date: June 2007

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

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Biological:
• Cetuximab
400 mg/m2 loading dose, 250 mg/m2 weekly X 2 Cycles

Locations

Country	Name	City	State
United States	ImClone Investigational Site	Birmingham	Alabama
United States	ImClone Investigational Site	New York	New York
United States	ImClone Investigational Site	Orlando	Florida
United States	ImClone Investigational Site	Philadelphia	Pennsylvania
United States	ImClone Investigational Site	Seattle	Washington

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	Overall response rate		Every six weeks	No
Secondary	Relationship between response, dose, and occurence of rash		Every six weeks	No