Pemetrexed in Patients With Advanced Neuroendocrine Tumors

Dana-Farber Cancer Institute

Status and phase

Completed

Phase 2

Conditions

Neuroendocrine Tumors

Treatments

Drug: Pemetrexed

Study type

Interventional

Funder types

Other

Identifiers

05-309

Details and patient eligibility

About

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

Full 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.

Enrollment

32 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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