MDACC Study Summary GOG 0188 (Archived)

Study Summary
No. GOG 0188:.......Endometrial......Lois M. Ramondetta......Gynecologic Oncology

Study Summary Title



Study Summary Number:	GOG 0188

Study Title:	A Phase II Study of Faslodex in Recurrent/Metastatic Endometrial Carcinoma

Physician

New Patient Referral



Name:	Lois M. Ramondetta	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:	713-745-0307 Contact us about clinical trials

General Information



Disease Group:	Endometrial	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	monthly

Treatment Agents:	Faslodex	Home Care:	none

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	n/a

Description/
Intervention:

The goal of this clinical research study is to look at the effectiveness of
Faslodex® (fulvestrant) in treating endometrial (uterine) cancer that has
spread to other parts of the body or has come back after treatment. The safety
of this treatment will also be studied.

Researchers also want to find out if patients who have certain hormone
receptors respond differently to treatment with fulvestrant than those who do
not have these receptors. Hormone receptors are proteins on the surface of
cells that bind to a specific hormone. The hormone causes many changes to take
place in the cell.

Study Objectives / Outcomes

To estimate the probability of clinical response of Faslodex in patients with persistent or recurrent endometrial carcinoma. This probability of response will be estimated separately among patients expressing the estrogen receptor and among patients not expressing the estrogen receptor.

To explore the relationship between response rate and intensity of receptor expression.

To estimate the frequency and severity of toxicity of Faslodex in this cohort of patients.

Study Status Information



Study Activation / Registration Date:	11/29/2006

IRB Review and Approval Date:	09/06/2006

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Terminated

Projected Accrual:	95

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 histologically and cytologically confirmed endometrial cancer that is recurrent, persistent or metastatic and is not curable with either surgery or radiation therapy.

2) Immunohistochemical analysis of metastatic or recurrent tumor tissue (for estrogen and progesterone receptors) must be obtained by biopsy or FNA cytology.

3) Estrogen receptor positive and estrogen receptor negative patients are eligible for this study. NB: This study is closed to estrogen receptor positive patients effective August 13, 2007.

4) Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST. Tumors within a previously irradiated field will be generally designated as "nontarget" lesions. Disease in an irradiated field as the only site of measurable disease is acceptable as a target lesion only if there has been clear progression of the lesion since the completion of radiation treatment.

5) Patients must have a GOG Performance Status of 0 or 1.

6) Patients must have adequate: a) Bone Marrow Function: ANC >/= 1500/mcl, platelet count >/= 100,000/mcl. b) Renal Function: serum creatinine </= 2 mg%. c) Hepatic Function: Bilirubin </= 1.5 times ULN, and SGOT and alkaline phosphatase </= 3 x ULN.

7) Patients may have received prior surgery, radiation therapy or hormonal treatment. However, at least 3 weeks must have elapsed from the prior therapy, and acute side effects must be resolved prior to protocol entry.

8) Patients may have received one chemotherapy regimen directed at a newly diagnosed endometrial carcinoma; if they have received a chemotherapy regimen, they must have subsequently recurred.

9) Patients must have met the pre-entry requirements per the Pre-entry/Pre-treatment parameters in the Patient/Participant Evaluation section which follows.

10) Patients must have signed an approved informed consent and authorization permitting release of personal health information.

11) Patients who have not had a hysterectomy must have been surgically sterilized, use reliable contraception, be postmenopausal, or have a negative serum pregnancy test within 7 days of initiating therapy.

Exclusion Criteria:

1) Patients who are pregnant or lactating.

2) Patients with a concomitant malignancy other than non-melanoma skin cancer. Patients with a prior malignancy who have been disease-free for < 5 years or who received prior chemotherapy for that malignancy.

3) Patients with a history of bleeding diathesis (DIC, clotting factor deficiency, anticoagulants).

4) Patients with hypersensitivity to Castor Oil.

5) Patients who have received chemotherapy directed at persistent or recurrent endometrial carcinoma.

Links

Registration Number: NCT00006903
Study Information on Clinical Trials Registry (clinicaltrials.gov)