Pemetrexed in Patients With Advanced Neuroendocrine Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out what effects (good and bad) pemetrexed has on patients with advanced neuroendocrine tumors.

Detailed Description
-----------------
1 cycle is equal to 21 days. Every 21 days the following will be performed: a review of the patients symptoms and medications; physical exam; blood tests; vital signs; and pemetrexed infusion. Every 3 cycles (9 weeks) an assessment of disease extent by CT scan and a 24 hour urine collection (if applicable) will be performed. Before patients start receiving pemetrexed, they will be given folic acid, vitamin B12 and dexamethasone to help reduce the chance of significant side effects. Dexamethasone will be taken the evening before, the morning before and the evening after receiving pemetrexed. Folic acid should be taken daily beginning 5-7 days before the first dose of pemetrexed and should be continued for three weeks after the last dose of pemetrexed. Vitamin B12 will be given as an injection 1-2 weeks before the first dose of pemetrexed and once every 9 weeks until 3 weeks after the last dose of pemetrexed. Patients can continue to receive treatment with pemetrexed unless there is evidence that their tumor has grown or they are experiencing serious side effects. Immediately after the patient has completed the study, they will be given a physical exam, including vital signs, a CT scan, and blood tets. The study staff will continue to monitor the patients health either by clinic visits or phone calls every three months for the remainder of your life.

Official Title
-----------------
A Phase II Study of Pemetrexed in Patients With Advanced Neuroendocrine Tumors

Conditions
-----------------
Neuroendocrine Tumors

Intervention / Treatment
-----------------
* Drug: Pemetrexed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Metastatic or locally unresectable neuroendocrine tumor, excluding small cell carcinoma Measurable tumor 18 year of age or older ECOG performance status of 0,1 or 2 Life expectancy of greater than 12 weeks WBC: > 3.0/mm3 Plts: > 100,000/mm3 Bilirubin: < 2.0 mg/dl AST < 3 x ULN (except in patients with known hepatic metastases wherein SST may be < 5 x ULN) Neutrophils > 1000/mm3 Creatinine Clearance > 45 ml/min. Should be measured using the standard Cockroft-Gault formula Exclusion Criteria: Prior treatment with pemetrexed Clinically apparent central nervous system metastases or carcinomatous meningitis Myocardial infarction in the past 6 months Major surgery in the past two weeks Uncontrolled serious medical or psychiatric illness Pregnant or lactating women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

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

| Intervention/Treatment |
| --- |
|Drug: Pemetrexed|Given intravenously over 10 minutes every 21 days (21 days equals one cycle). Subjects will continue to receive pemetrexed as long as their disease does not worsen and they do not experience any serious side effects.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the radiologic response rate associated with pemetrexed in patients with neuroendocrine tumors. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To perform an analysis of the biochemical response rate |  | 2 years | 
| to assess the toxicity associated with pemetrexed |  | 2 years | 
| and to assess the progression-free and overall survival of patients. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pemetrexed, neuroendocrine tumors, metastatic neuroendocrine tumors