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

Phase 2
18 Years
Not Enrolling
Neuroendocrine Tumors

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Trial Information

A Phase II Study of Pemetrexed in 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.

Inclusion Criteria:

- Metastatic or locally unresectable neuroendocrine tumor, excluding small cell

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the radiologic response rate associated with pemetrexed in patients with neuroendocrine tumors.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Matthew Kulke, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

December 2005

Completion Date:

March 2010

Related Keywords:

  • Neuroendocrine Tumors
  • pemetrexed
  • neuroendocrine tumors
  • metastatic neuroendocrine tumors
  • Neuroendocrine Tumors



Dana-Farber Cancer Center Boston, Massachusetts  02115