Status:
COMPLETED
Pemetrexed in Patients With Advanced Neuroendocrine Tumors
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Conditions:
Neuroendocrine Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. * Eve...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00424723
Start Date
December 1 2005
End Date
March 1 2010
Last Update
August 12 2010
Active Locations (1)
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1
Dana-Farber Cancer Center
Boston, Massachusetts, United States, 02115