MDACC Study Summary ID00-418

Study Summary
No. ID00-418:.......Gynecology......Anuja Jhingran......Radiation Oncology

Study Summary Title



Study Summary Number:	ID00-418

Study Title:	A Phase II Study: Paclitaxel and Pelvic Radiation for Stage I-IIIA Papillary Serous Carcinoma of the Endometrium

Physician

New Patient Referral



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

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

Phone:	713-563-6900 Contact us about clinical trials

General Information



Disease Group:	Gynecology	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	After treatment, patients must return every three months for the 1st two years, every four months for the 3rd year, and every six months for the 4th and 5th year. After that, it will be annually.

Treatment Agents:	Paclitaxel	Home Care:	N/A

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	No hospitalization required


Description/ Intervention:	The goal of this clinical research study is to study how a combination of paclitaxel and pelvic radiation helps to control papillary serous carcinoma confined to the pelvis. The safety of this combination, as well as the side effects and quality of life during these treatments, will also be studied.

Study Objectives / Outcomes

1. To evaluate the results of Paclitaxel and pelvic radiation in pelvic confined papillary serous carcinoma of the endometrium for both local control and overall survival.
2. To evaluate the toxicity of Paclitaxel and pelvic radiation.
3. To collect and evaluate patients' quality of life/symptom assessment data.

Study Status Information



Study Activation / Registration Date:	04/30/2001

IRB Review and Approval Date:	03/21/2001

Study Type:	Therapeutic

Recruitment Status:	Closed

Projected Accrual:	49

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) Patient must undergo surgical staging within 8 weeks of study entry.

2) Patients with mixed histology tumor that include a papillary serous component are eligible.

3) Only patients with non-measurable disease can be entered.

4) Patients may not have had previous chemotherapy or radiation therapy.

5) Patients must have an estimated life expectancy of 12 weeks or greater.

6) Patients must have a Zubrod performance status of less than or equal to 2.

7) Patients must have adequate bone marrow, renal and hepatic function: with WBC greater than or equal to 3000; ANC greater than or equal to 1500; Platelets greater than or equal to 100,000; SGPT less than or equal to 2x the upper limit of normal; Total bilirubin less than or equal to 2.5mg/dl.

8) Patients must sign an institutionally approved consent form.

Exclusion Criteria:

1) Previously treated papillary serous carcinoma with either chemotherapy or radiation therapy.

2) Newly diagnosed papillary serous carcinoma of the endometrium, Stage IIIB-IV (patients with disease outside the pelvis).

3) Patients who have a history of other malignancy, with the exception of non-melanomatous skin cancer, unless in complete remission and off all therapy for that disease for a minimum of 5 years.

4) Patients with a Zubrod status of 3 or greater.

5) Patients with an active infection.

6) Patients with serious intercurrent medical illness.

7) Patients with a recent (within 6 months) history of congestive heart failure, unstable angina or myocardial infarction.

Links

Registration Number: NCT00515073
Study Information on Clinical Trials Registry (clinicaltrials.gov)