MDACC Study Summary 2006-0211 (Archived)

Study Summary
No. 2006-0211:.......Endometrial; Uterus......Judith Wolf......Gynecologic Oncology

Study Summary Title



Study Summary Number:	2006-0211

Study Title:	Phase II Study of Cetuximab (Erbitux) in Patients with Progressive or Recurrent Endometrial Cancer

Physician

New Patient Referral



Name:	Judith Wolf	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Gynecologic Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-794-1422 Contact us about clinical trials

General Information



Disease Group:	Endometrial Uterus	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Weekly

Treatment Agents:	Cetuximab	Home Care:	Not applicable

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	Not applicable


Description/ Intervention:	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.

Study Objectives / Outcomes

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.

Study Status Information



Study Activation / Registration Date:	10/10/2006

IRB Review and Approval Date:	08/02/2006

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Terminated

Projected Accrual:	40

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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.

Links

Registration Number: NCT00392769
Study Information on Clinical Trials Registry (clinicaltrials.gov)