MDACC Study Summary 2006-0453

Study Summary
No. 2006-0453:.......Sarcoma; Uterus......Robert Coleman......Gynecologic Oncology

Study Summary Title



Study Summary Number:	2006-0453

Study Title:	A Randomized Phase II Study of Letrozole Versus Observation in Patients with Newly Diagnosed Uterine Leiomyosarcoma

Physician

New Patient Referral



Name:	Robert Coleman	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:	Sarcoma Uterus	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Every 12 weeks (+/- 7 days)

Treatment Agents:	Letrozole	Home Care:	None

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Not applicable


Description/ Intervention:	The goal of this clinical research study is learn if taking Femara (letrozole) after a hysterectomy (surgical removal of the uterus) for uterine leiomyosarcoma will delay or prevent the cancer from coming back.

Study Objectives / Outcomes

To prolong the time to recurrence for patients with clinical stage I and II uterine LMS assigned to letrozole therapy. The primary endpoint of this study will be a prolongation of time to disease recurrence.

Study Status Information



Study Activation / Registration Date:	12/19/2006

IRB Review and Approval Date:	10/18/2006

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

Projected Accrual:	80

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 uterine leiomyosarcoma with disease limited to the uterus (determined by surgical staging or radiologic imaging).

3) Tumors must express ER positivity by immunohistochemistry (ER expression >10% by immunohistochemistry).

4) Patients must have a hysterectomy and bilateral oophorectomy prior to initiation of therapy.

5) All patients must have no measurable disease. Measurable disease is defined as lesions that can be measured by physical examination or by means of imaging techniques. Imaging must be done within 6 weeks of study entry.

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

7) Patients must have a pretreatment granulocyte count (i.e., segmented neutrophils + bands) of greater than 1,000/Fl, a hemoglobin level of greater than or equal to 9.0 gm/dL and a platelet count of greater than 75,000/dL.

8) Patients must have an adequate renal function as documented by serum creatinine less than or equal to 2.0 mg/dL.

9) Patients must have adequate hepatic function as documented by a serum bilirubin less than or equal to 2.5 mg/dL.

10) Aspartate transaminase (SGOT) must be less than 3x institutional upper limit of normal.

11) Patients must have recovered from the effects of prior surgery.

12) No more than 12 weeks must have elapsed from hysterectomy.

13) Patients must be 18 years or older.

Exclusion Criteria:

1) Patients who do not have pure uterine sarcomas (i.e., no mixed malignant Mullerian tumors).

2) 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.

3) 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.

4) Patients who were taking or have a history of taking letrozole or another aromatase inhibitor.

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 are pregnant or breast-feeding.

8) Presence of clinically apparent untreated central nervous system metastases.

9) Presence of carcinomatous meningitis.

10) Patients currently receiving chemotherapy or radiation therapy.

Links

Registration Number: NCT00414076
Study Information on Clinical Trials Registry (clinicaltrials.gov)