A Trial for Patients With Advanced/Recurrent Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
The intent of this protocol is to screen a new agent for activity in patients with advanced or recurrent endometrial carcinoma. This phase II trial is studying how well pemetrexed disodium works in treating patients with advanced or recurrent endometrial carcinoma.

Official Title
-----------------
A Phase II Evaluation of Pemetrexed in the Treatment of Recurrent or Persistent Endometrial Carcinoma

Conditions
-----------------
Neoplasms, Neoplasms by Site, Urogenital Neoplasms, Genital Neoplasms, Female, Uterine Neoplasms, Endometrial Neoplasms, Cancer of Endometrium, Endometrial Cancer, Cancer of the Endometrium, Endometrium Cancer, Neoplasms, Endometrial

Intervention / Treatment
-----------------
* Drug: pemetrexed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have recurrent or persistent endometrial adenocarcinoma, which is refractory to curative therapy or established treatments. Patients must have measurable disease. Patients must have had one prior chemotherapeutic regimen for management of endometrial carcinoma. Patients must have signed an approved informed consent. Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception during the study and for at least 3 months following the last dose of Pemetrexed. Patients must discontinue nonsteroidal anti-inflammatory (NSAIDs) medications 2-5 days prior to and for 1-2 days after receiving Pemetrexed, depending on the half-life of the NSAIDs treatment. Patients must agree to this schedule in conjunction with every dose of Pemetrexed. Patients must receive 350-1000 mcg of folic acid (e.g. one prenatal vitamin) starting 7 days prior to the first treatment with Pemetrexed. Patients must be able to ingest 350-1000 mcg of folic acid daily until 3 weeks after the last dose of Pemetrexed. Patients must receive 4 mg Dexamethasone by mouth twice daily, 1 day prior to the dose, the day of and the day after every dose of Pemetrexed. Patients must receive a 1000 mcg vitamin B12 injection 7 days prior to receiving the first treatment with Pemetrexed. Patients must agree to receive 1000 mcg vitamin B12 injection every 9 weeks until 3 weeks after the last dose of Pemetrexed. Exclusion Criteria: Patients who have had prior therapy with Pemetrexed Patients who have received radiation to more than 25% of marrow bearing areas
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pemetrexed<br> | Drug: pemetrexed<br>* 900 mg/m2, intravenous (IV), every 21 days, until disease progression<br>* Other names: Alimta;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Response | Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment. Complete response (CR) = disappearance of all target lesions; Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable disease (SD) = small changes that do not meet above criteria. | baseline to measured progressive disease (up to 24 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Adverse events were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). The worst grade event per cycle is reported. | every 21-day cycle (up to 24 months) |