Endometrial CancerPhase 2NCT00392769
Cetuximab in Patients With Progressive or Recurrent Endometrial Cancer
A Phase 2 study testing Cetuximab in people with Endometrial Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
The goal of this clinical research study is to learn if cetuximab can help to control the disease in patients who have recurrent endometrial cancer. Primary Objective: 1. To determine the overall disease control rate of cetuximab in patients with progressive or recurrent endometrial cancer. Secondary Objectives: 1. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2006to Dec 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have signed an approved informed consent.
- Histologically confirmed progressive or recurrent endometrial cancer (endometrioid, serous, clear cell, mixed malignant Mullerian tumors, or mixed histology; any grade).
- Patients must have failed at least one prior chemotherapeutic regimen for recurrent disease (does not include chemosensitizing radiation).
- All patients must have measurable disease. Measurable disease is defined as lesions that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be > 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or > 10 mm when measured by spiral CT. Ascites and pleural effusions are not considered measurable disease. If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology.
- Patients must have a Zubrod performance status of 0, 1, or 2.
- Patients must either be not of child bearing potential or have a negative pregnancy test within 7 days of treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal for greater than 12 months.
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- Patients must have a pretreatment granulocyte count (i.e., segmented neutrophils + bands) of >1,000/Fl, a hemoglobin level of >/= 9.0 gm/dL and a platelet count of >75,000/Fl.
- Patients must have an adequate renal function as documented by serum creatinine </= 2.0 mg/dL.
- Patients must have adequate hepatic function as documented by a serum bilirubin </= 2.5 mg/dL, regardless of whether patients have liver involvement secondary to tumor.
- Aspartate transaminase (SGOT) must be </= 3x institutional upper limit of normal unless the liver is involved with tumor, in that case, the aspartate transaminase must be </=5 x institutional upper limit of normal.
- Prior to beginning therapy, at least 4 weeks must have elapsed since prior chemotherapy, surgery, radiation therapy or investigational therapy. Patients receiving palliative radiation therapy are exempt from the 4 week waiting period.
Who cannot join
- Patients who have uterine sarcomas.
- Patients who have isolated recurrences (vaginal, pelvic, or paraaortic) that are amenable to potentially curative treatment with radiation therapy or surgery.
- Patients with any other severe concurrent disease, which would make the patient inappropriate for entry into this study, including significant hepatic, renal, or gastrointestinal diseases.
- Patients with a history of prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least five years.
- Patients with active or uncontrolled systemic infection.
- Patients with history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with an ejection fraction under 40%.
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- Patients who received prior therapy that specifically and directly targets the EGFR pathway.
- Patients who experienced prior severe infusion reaction to a monoclonal antibody.
- Patients who are pregnant or breast feeding.
- Presence of clinically apparent untreated central nervous system metastases.
- Patients with carcinomatous meningitis.
- Patients with deep venous or arterial thrombosis (including pulmonary embolism) within 6 weeks of study entry. Patients may be on maintenance anticoagulation therapy.
- Patients with previously documented human immunodeficiency virus (HIV) infection.
- Patients currently receiving chemotherapy or radiation therapy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UT MD . Anderson Cancer Center
Houston, Texas, 77030
New York Presbyterian Hospital-Cornell Medical Center
New York, New York, 10021
About this study
Official title: Phase II Study of Cetuximab (Erbitux) in Patients With Progressive or Recurrent Endometrial Cancer
The goal of this clinical research study is to learn if cetuximab can help to control the disease in patients who have recurrent endometrial cancer.
Primary Objective:
- To determine the overall disease control rate of cetuximab in patients with progressive or recurrent endometrial cancer.
Secondary Objectives:
- To determine the duration of disease control, time to disease progression, and survival of this cohort of patients.
- To determine the nature and degree of toxicity of cetuximab in this cohort of patients.
- To correlate biologic markers with response to therapy if tissue is available.
Read the detailed description
The epidermal growth factor receptor (EGFR) is a large protein that plays an important role in tumor growth. When EGFR is stimulated or "overexpressed," a series of chemical reactions happen that result in a tumor being "told" to grow. Researchers know that EGFR is overexpressed in many types of endometrial cancer. Cetuximab is designed to block this receptor, which may help to stop or slow the growth of tumors in those patients whose endometrial cancer has come back.
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in the study. If you have had some of the tests done recently, they may not need to be repeated. Your complete medical history will be recorded. You will have a physical exam, including a pelvic exam and measurement of vital signs (blood pressure, heart rate, temperature, and breathing rate). Blood (about 2-3 teaspoons) will be drawn for routine tests, tests of your kidney and liver function, and a pregnancy test for women who are able to have children. The pregnancy test must be negative for you to be allowed to take part in this study. You will have a chest x-ray and computed tomography (CT) or magnetic resonance imaging (MRI) scans of the abdomen and pelvis (stomach and hip area) to measure the tumor.
If you are found to be eligible to take part in this study, you will receive cetuximab once a week through a needle in a vein. Each treatment cycle is 4 weeks long. In the first week of your first treatment cycle only, you will receive cetuximab over 120 minutes (2 hours). For all additional treatments, you will receive cetuximab over 60 minutes. During the infusion and for 60 minutes after the infusion ends, you will be closely watched for signs of an allergic reaction.
You will receive diphenhydramine (or a similar antihistamine) by vein, about 30-60 minutes before receiving each cetuximab infusion. This is in order to lower the risk of side effects that the study drug may cause. Your doctor may decide to lower the dose of diphenhydramine in later doses.
Before each cycle of therapy and 1 month after treatment ends, you will have a physical exam. Blood (about 2-3 teaspoons) will be drawn for routine tests. CT scans or MRI will be repeated every 2-3 cycles and at the end of treatment. If you have any tumors in your chest, a chest x-ray will be repeated every 2-3 cycles and at the end of treatment. If you have a partial or complete response (the tumor shrinks or disappears completely) or the disease is stable (where the tumor has neither grown nor shrunk), the CT or MRI will be repeated 4 weeks later to check the response.
You will be able to keep receiving additional treatment cycles as long as you are benefitting. If the disease gets worse or you experience any intolerable side effects, you will be taken off the study.
After you have completed treatment on the study, the status of your health and the disease will be checked. Your doctor will decide how often these check-ups will occur. You may return to M. D. Anderson for these follow-up exams, or if you choose not to come in to the clinic, you will be contacted by phone to see how you are doing.
This is an investigational study. Cetuximab is commercially available and FDA approved for the treatment of colorectal cancer. Its use in the treatment of endometrial cancer in this study is experimental. Up to 40 patients will take part in this study. Up to 30 patients will be enrolled at M. D. Anderson.
- Conditions
- Endometrial Cancer
- Being tested
- Cetuximab
- Keywords
- Endometrial Cancer, Progressive or Recurrent Endometrial Cancer, Cetuximab, C225, Erbitux™, IMC-C225, Epidermal growth factor receptor, EGFR, Endometrioid Tumor, Serous Tumor, Clear cell Tumor, Mixed malignant Mullerian Tumors
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Also called C225, Erbitux™, IMC-C225
Initial Dose = 400 mg/m^2 IV Over 120 Minutes, Followed by Weekly Infusions at 250 mg/m^2 IV Over 60 Minutes.
| Study group | Role | What they receive |
|---|---|---|
| Cetuximab | Experimental | 400 mg/m^2 intravenous (IV) over 120 Minutes, followed by weekly infusions at 250 mg/m^2 IV over 60 minutes. Receives: Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Disease Control Rate
Overall disease control rate also called the Clinical Benefit Response (CBR) is defined as Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) evaluated within 8 weeks (CR or PR) and 12 weeks (SD) of initial treatment, using Bayesian design.
Measured: Overall disease control rate (CR + PR + SD) evaluated within 8 weeks (CR or PR) and 12 weeks (SD) of initial treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Judith Wolf, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00392769
- Sponsor's protocol ID
- 2006-0211
- Status last verified
- Aug 2012
- First submitted
- 25 Oct 2006
- Last updated
- 6 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Cetuximab (Erbitux) in Patients With Progressive or Recurrent Endometrial Cancer
- ClinicalTrials.gov ID
- NCT00392769
- Acronym / sponsor ID
- 2006-0211
- Conditions
- Endometrial Cancer
- Keywords
- Endometrial Cancer, Progressive or Recurrent Endometrial Cancer, Cetuximab, C225, Erbitux™, IMC-C225, Epidermal growth factor receptor, EGFR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Oct 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 26 Oct 2006 (estimated)
- Results
- Posted 6 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if cetuximab can help to control the disease in patients who have recurrent endometrial cancer.
Primary Objective:
- To determine the overall disease control rate of cetuximab in patients with progressive or recurrent endometrial cancer.
Secondary Objectives:
- To determine the duration of disease control, time to disease progression, and survival of this cohort of patients.
- To determine the nature and degree of toxicity of cetuximab in this cohort of patients.
- To correlate biologic markers with response to therapy if tissue is available.
Detailed description
The epidermal growth factor receptor (EGFR) is a large protein that plays an important role in tumor growth. When EGFR is stimulated or "overexpressed," a series of chemical reactions happen that result in a tumor being "told" to grow. Researchers know that EGFR is overexpressed in many types of endometrial cancer. Cetuximab is designed to block this receptor, which may help to stop or slow the growth of tumors in those patients whose endometrial cancer has come back.
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in the study. If you have had some of the tests done recently, they may not need to be repeated. Your complete medical history will be recorded. You will have a physical exam, including a pelvic exam and measurement of vital signs (blood pressure, heart rate, temperature, and breathing rate). Blood (about 2-3 teaspoons) will be drawn for routine tests, tests of your kidney and liver function, and a pregnancy test for women who are able to have children. The pregnancy test must be negative for you to be allowed to take part in this study. You will have a chest x-ray and computed tomography (CT) or magnetic resonance imaging (MRI) scans of the abdomen and pelvis (stomach and hip area) to measure the tumor.
If you are found to be eligible to take part in this study, you will receive cetuximab once a week through a needle in a vein. Each treatment cycle is 4 weeks long. In the first week of your first treatment cycle only, you will receive cetuximab over 120 minutes (2 hours). For all additional treatments, you will receive cetuximab over 60 minutes. During the infusion and for 60 minutes after the infusion ends, you will be closely watched for signs of an allergic reaction.
You will receive diphenhydramine (or a similar antihistamine) by vein, about 30-60 minutes before receiving each cetuximab infusion. This is in order to lower the risk of side effects that the study drug may cause. Your doctor may decide to lower the dose of diphenhydramine in later doses.
Before each cycle of therapy and 1 month after treatment ends, you will have a physical exam. Blood (about 2-3 teaspoons) will be drawn for routine tests. CT scans or MRI will be repeated every 2-3 cycles and at the end of treatment. If you have any tumors in your chest, a chest x-ray will be repeated every 2-3 cycles and at the end of treatment. If you have a partial or complete response (the tumor shrinks or disappears completely) or the disease is stable (where the tumor has neither grown nor shrunk), the CT or MRI will be repeated 4 weeks later to check the response.
You will be able to keep receiving additional treatment cycles as long as you are benefitting. If the disease gets worse or you experience any intolerable side effects, you will be taken off the study.
After you have completed treatment on the study, the status of your health and the disease will be checked. Your doctor will decide how often these check-ups will occur. You may return to M. D. Anderson for these follow-up exams, or if you choose not to come in to the clinic, you will be contacted by phone to see how you are doing.
This is an investigational study. Cetuximab is commercially available and FDA approved for the treatment of colorectal cancer. Its use in the treatment of endometrial cancer in this study is experimental. Up to 40 patients will take part in this study. Up to 30 patients will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cetuximab | Experimental | Drug: Cetuximab400 mg/m^2 intravenous (IV) over 120 Minutes, followed by weekly infusions at 250 mg/m^2 IV over 60 minutes. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must have signed an approved informed consent.
- Histologically confirmed progressive or recurrent endometrial cancer (endometrioid, serous, clear cell, mixed malignant Mullerian tumors, or mixed histology; any grade).
- Patients must have failed at least one prior chemotherapeutic regimen for recurrent disease (does not include chemosensitizing radiation).
- All patients must have measurable disease. Measurable disease is defined as lesions that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be > 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or > 10 mm when measured by spiral CT. Ascites and pleural effusions are not considered measurable disease. If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology.
- Patients must have a Zubrod performance status of 0, 1, or 2.
Key exclusion criteria (14 listed)
- Patients who have uterine sarcomas.
- Patients who have isolated recurrences (vaginal, pelvic, or paraaortic) that are amenable to potentially curative treatment with radiation therapy or surgery.
- Patients with any other severe concurrent disease, which would make the patient inappropriate for entry into this study, including significant hepatic, renal, or gastrointestinal diseases.
- Patients with a history of prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least five years.
- Patients with active or uncontrolled systemic infection.
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: C225, Erbitux™, IMC-C225Initial Dose = 400 mg/m^2 IV Over 120 Minutes, Followed by Weekly Infusions at 250 mg/m^2 IV Over 60 Minutes. | Drug | Cetuximab |
Primary outcome
Overall Disease Control Rate
Time frame: Overall disease control rate (CR + PR + SD) evaluated within 8 weeks (CR or PR) and 12 weeks (SD) of initial treatment.
Overall disease control rate also called the Clinical Benefit Response (CBR) is defined as Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) evaluated within 8 weeks (CR or PR) and 12 weeks (SD) of initial treatment, using Bayesian design.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Judith Wolf, MD principal investigator
M.D. Anderson Cancer Center
2 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 Endometrial Cancer, run by M.D. Anderson Cancer Center at 2 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 11 inclusion and 14 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: finished, as of the sponsor's last update on 6 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 6 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Disease Control Rate (time frame: Overall disease control rate (CR + PR + SD) evaluated within 8 weeks (CR or PR) and 12 weeks (SD) of initial treatment.). 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 6 Sep 2012.