Ovarian CancerPhase 2NCT00082212
A Study in Patients With Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
A Phase 2 study testing Cetuximab in people with Ovarian Cancer, run by Eli Lilly and Company at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Cetuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2004to Jun 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
ImClone Investigational Site
Birmingham, Alabama, 35233
ImClone Investigational Site
New York, New York, 10021
ImClone Investigational Site
Orlando, Florida, 32804
ImClone Investigational Site
Philadelphia, Pennsylvania, 19111
ImClone Investigational Site
Seattle, Washington, 09104
About this study
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
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.
Read the 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.
- Conditions
- Ovarian Cancer
- Being tested
- Cetuximab
- Keywords
- ovarian, primary peritoneal cancer, Persistent or Recurrent Ovarian Cancer, Primary Peritoneal Carcinoma
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabBiological
Also called Erbitux
400 mg/m2 loading dose, 250 mg/m2 weekly X 2 Cycles
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 400 mg/m2 loading dose, 250 mg/m2 weekly X 2 Cycles Receives: Biological: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: Every six weeks
Secondary outcomes (1)
Relationship between response, dose, and occurence of rash
Measured: Every six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2004 (estimated)
- Study startNov 2004
- Primary completionJun 2007
- Study completionJun 2007
Why it stopped: Due to lack of sufficient efficacy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Investigators
- E-mail: ClinicalTrials@ ImClone.com, Study chair, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00082212
- Sponsor's protocol ID
- CA225-046
- Status last verified
- Apr 2010
- First submitted
- 3 May 2004
- Last updated
- 9 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00082212
- Acronym / sponsor ID
- CA225-046
- Conditions
- Ovarian Cancer
- Keywords
- ovarian, primary peritoneal cancer, Persistent or Recurrent Ovarian Cancer, Primary Peritoneal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to lack of sufficient efficacy.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Nov 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 5 May 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Cetuximab400 mg/m2 loading dose, 250 mg/m2 weekly X 2 Cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CetuximabAlso: Erbitux400 mg/m2 loading dose, 250 mg/m2 weekly X 2 Cycles | Biological | 1 |
Primary outcome
Overall response rate
Time frame: Every six weeks
1 secondary outcome
Relationship between response, dose, and occurence of rash
Time frame: Every six weeks
Results and safety
The study was stopped early (reason given: Due to lack of sufficient efficacy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
E-mail: ClinicalTrials@ ImClone.com study chair
Eli Lilly and Company
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab in people with Ovarian Cancer, run by Eli Lilly and Company at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to lack of sufficient efficacy.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: Every six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2010; AzTrials last refreshed its copy on 30 Oct 2026.