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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00082212

Enrollment

Registered

2004-05-05

Start date

2004-11-30

Completion date

2007-06-30

Last updated

2010-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

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

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.

Interventions

BIOLOGICALCetuximab

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Overall response rate	Every six weeks

Secondary

Measure	Time frame
Relationship between response, dose, and occurence of rash	Every six weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026