Neuroendocrine Tumors
Conditions
Keywords
pemetrexed, neuroendocrine tumors, metastatic neuroendocrine tumors
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.
Interventions
DRUGPemetrexed
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.
Sponsors
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Massachusetts General Hospital
Dana-Farber Cancer Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the radiologic response rate associated with pemetrexed in patients with neuroendocrine tumors. | 2 years |
Secondary
| Measure | 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. | — |
Countries
United States
Outcome results
None listed