Cetuximab in Patients With Progressive or Recurrent Endometrial Cancer
Condition: Endometrial Cancer
MeSH terms: Endometrial Neoplasms
Intervention: Cetuximab
Intervention description: Initial Dose = 400 mg/m^2 IV Over 120 Minutes, Followed by Weekly Infusions at 250 mg/m^2 IV Over 60 Minutes.
Intervention MeSH terms: Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: Female
Healthy volunteers: No
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

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. To determine the duration of disease control, time to disease progression, and survival
           of this cohort of patients.

        2. To determine the nature and degree of toxicity of cetuximab in this cohort of patients.

        3. To correlate biologic markers with response to therapy if tissue is available.
    

Eligibility criteria:

        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
             >75,000/Fl.

          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 </= 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.

         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
             pathway.

          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 therapy.

         13. Patients with previously documented human immunodeficiency virus (HIV) infection.

         14. Patients currently receiving chemotherapy or radiation therapy.