Clinical trial NCT00082212: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ovarian Cancer
Keywords: ovarian
primary peritoneal cancer
Persistent or Recurrent Ovarian Cancer
Primary Peritoneal Carcinoma
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2004-05-05
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall response rate
timeFrame: Every six weeks
Secondary outcomes:
measure: Relationship between response, dose, and occurence of rash
timeFrame: Every six weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: ImClone Investigational Site
state: Alabama
city: Orlando
country: United States
facility: ImClone Investigational Site
state: Florida
city: New York
country: United States
facility: ImClone Investigational Site
state: New York
city: Philadelphia
country: United States
facility: ImClone Investigational Site
state: Pennsylvania
city: Seattle
country: United States
facility: ImClone Investigational Site
state: Washington
Study officials:
affiliation: Eli Lilly and Company
name: E-mail: ClinicalTrials@ ImClone.com
role: STUDY_CHAIR
References: