Pemetrexed in Patients With Advanced Neuroendocrine Tumors
A Phase II Study of Pemetrexed in Patients With Advanced Neuroendocrine Tumors
1 other identifier
interventional
32
1 country
1
Brief Summary
The purpose of this study is to find out what effects (good and bad) pemetrexed has on patients with advanced neuroendocrine tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2005
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 18, 2007
CompletedFirst Posted
Study publicly available on registry
January 19, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedAugust 12, 2010
August 1, 2010
1.1 years
January 18, 2007
August 10, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the radiologic response rate associated with pemetrexed in patients with neuroendocrine tumors.
2 years
Secondary Outcomes (3)
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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Metastatic or locally unresectable neuroendocrine tumor, excluding small cell carcinoma
- Measurable tumor
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Beth Israel Deaconess Medical Centercollaborator
- Brigham and Women's Hospitalcollaborator
- Massachusetts General Hospitalcollaborator
Study Sites (1)
Dana-Farber Cancer Center
Boston, Massachusetts, 02115, United States
Related Publications (1)
Chan JA, Zhu AX, Stuart K, Bhargava P, Earle CC, Clark JW, Casey C, Regan E, Kulke MH. Phase II study of pemetrexed in patients with advanced neuroendocrine tumors. Cancer Chemother Pharmacol. 2010 Oct;66(5):961-8. doi: 10.1007/s00280-010-1248-6. Epub 2010 Feb 4.
PMID: 20130879RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew Kulke, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 18, 2007
First Posted
January 19, 2007
Study Start
December 1, 2005
Primary Completion
January 1, 2007
Study Completion
March 1, 2010
Last Updated
August 12, 2010
Record last verified: 2010-08