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A Phase II Trial of Single-agent Cetuximab Dose Escalated to Rash in Patients With Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

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Trial Information

A Phase II Trial of Single-agent Cetuximab Dose Escalated to Rash in Patients With Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall response rate

Outcome Time Frame:

Every six weeks

Safety Issue:

No

Principal Investigator

E-mail: ClinicalTrials@ ImClone.com

Investigator Role:

Study Chair

Investigator Affiliation:

ImClone LLC

Authority:

United States: Food and Drug Administration

Study ID:

CA225-046

NCT ID:

NCT00082212

Start Date:

November 2004

Completion Date:

June 2007

Related Keywords:

  • Ovarian Cancer
  • ovarian
  • primary peritoneal cancer
  • Persistent or Recurrent Ovarian Cancer
  • Primary Peritoneal Carcinoma
  • Carcinoma
  • Ovarian Neoplasms

Name

Location

ImClone Investigational SiteNew York, New York  10021
ImClone Investigational SiteJacksonville, Florida  32207
ImClone Investigational SitePhiladelphia, Pennsylvania  19107
ImClone Investigational SiteSeattle, Washington  98104
ImClone Investigational SiteBirmingham, Alabama  35233