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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2007-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ovarian Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type EXPERIMENTAL

Cetuximab

Intervention Type BIOLOGICAL

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

Interventions

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Cetuximab

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Erbitux

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No