Pemetrexed in Patients With Advanced Neuroendocrine Tumors - Full Text View

Sponsor:	Dana-Farber Cancer Institute
Collaborators:	Beth Israel Deaconess Medical Center Brigham and Women's Hospital Massachusetts General Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00424723

Purpose

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

Condition	Intervention	Phase
Neuroendocrine Tumors	Drug: Pemetrexed	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study of Pemetrexed in Patients With Advanced Neuroendocrine Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Pemetrexed Pemetrexed disodium

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To assess the radiologic response rate associated with pemetrexed in patients with neuroendocrine tumors. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To perform an analysis of the biochemical response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
to assess the toxicity associated with pemetrexed [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
and to assess the progression-free and overall survival of patients. [ Time Frame: TBD ] [ Designated as safety issue: No ]

Estimated Enrollment:	32
Study Start Date:	December 2005
Estimated Study Completion Date:	January 2010
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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.
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00424723

Locations

United States, Massachusetts
Dana-Farber Cancer Center
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Beth Israel Deaconess Medical Center

Brigham and Women's Hospital

Massachusetts General Hospital

Investigators

Principal Investigator:

Matthew Kulke, MD

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Dana-Farber Cancer Institute ( Matthew Kulke, MD )
Study ID Numbers:	05-309
Study First Received:	January 18, 2007
Last Updated:	October 30, 2009
ClinicalTrials.gov Identifier:	NCT00424723 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:

pemetrexed
neuroendocrine tumors
metastatic neuroendocrine tumors

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Enzyme Inhibitors
Folic Acid Antagonists

Pharmacologic Actions
Neuroendocrine Tumors
Pemetrexed
Neuroectodermal Tumors
Neoplasms
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2009