Pemetrexed in Patients With Advanced Neuroendocrine Tumors

Official Title: “A Phase II Study of Pemetrexed in Patients With Advanced Neuroendocrine Tumors”

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

- 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.

Intervention(s) in this Clinical Trial

• 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.

Primary Measures

• To assess the radiologic response rate associated with pemetrexed in patients with neuroendocrine tumors.
  • Time Frame: 2 years
    Safety Issue?: No

Secondary Measures

• To perform an analysis of the biochemical response rate
  • Time Frame: 2 years
    Safety Issue?: No
• to assess the toxicity associated with pemetrexed
  • Time Frame: 2 years
    Safety Issue?: Yes
• and to assess the progression-free and overall survival of patients.
  • Time Frame: TBD
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Dana-Farber Cancer Institute Other

Overall Clinical Trial Officials and Contacts

Matthew Kulke, MD Principal Investigator Dana-Farber Cancer Institute  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00424723

Study ID Number: 05-309

ClinicalTrials.gov Identifier: NCT00424723

Health Authority: United States: Food and Drug Administration