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Phase II Study of Cetuximab (Erbitux) in Patients With Progressive or Recurrent Endometrial Cancer

Phase 2
Not Enrolling
Endometrial Cancer

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Trial Information

Phase II Study of Cetuximab (Erbitux) in Patients With Progressive or Recurrent Endometrial Cancer

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.

Inclusion Criteria:

1. Patients must have signed an approved informed consent.

2. Histologically confirmed progressive or recurrent endometrial cancer (endometrioid,
serous, clear cell, mixed malignant Mullerian tumors, or mixed histology; any grade).

3. Patients must have failed at least one prior chemotherapeutic regimen for recurrent
disease (does not include chemosensitizing radiation).

4. 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.

5. Patients must have a Zubrod performance status of 0, 1, or 2.

6. 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.

7. 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

8. Patients must have an adequate renal function as documented by serum creatinine 2.0 mg/dL.

9. 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.

10. Aspartate transaminase (SGOT) must be unless the liver is involved with tumor, in that case, the aspartate transaminase
must be
11. 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.

Exclusion Criteria:

1. Patients who have uterine sarcomas.

2. Patients who have isolated recurrences (vaginal, pelvic, or paraaortic) that are
amenable to potentially curative treatment with radiation therapy or surgery.

3. 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.

4. 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.

5. Patients with active or uncontrolled systemic infection.

6. 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%.

7. Patients who received prior therapy that specifically and directly targets the EGFR

8. Patients who experienced prior severe infusion reaction to a monoclonal antibody.

9. Patients who are pregnant or breast feeding.

10. Presence of clinically apparent untreated central nervous system metastases.

11. Patients with carcinomatous meningitis.

12. Patients with deep venous or arterial thrombosis (including pulmonary embolism)
within 6 weeks of study entry. Patients may be on maintenance anticoagulation

13. Patients with previously documented human immunodeficiency virus (HIV) infection.

14. Patients currently receiving chemotherapy or radiation therapy.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Disease Control Rate

Outcome Description:

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.

Outcome Time Frame:

Overall disease control rate (CR + PR + SD) evaluated within 8 weeks (CR or PR) and 12 weeks (SD) of initial treatment.

Safety Issue:


Principal Investigator

Judith Wolf, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

October 2006

Completion Date:

December 2010

Related Keywords:

  • Endometrial Cancer
  • 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
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma



UT MD . Anderson Cancer Center Houston, Texas  77030
New York Presbyterian Hospital-Cornell Medical Center New York, New York  10021