Pemetrexed in Patients With Advanced Neuroendocrine Tumors - Tabular View

Tracking Information

First Received Date ^ICMJE

January 18, 2007

Last Updated Date

October 30, 2009

Start Date ^ICMJE

December 2005

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00424723 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

To perform an analysis of the biochemical response rate
to assess the toxicity associated with pemetrexed
and to assess the progression-free and overall survival of patients.

Descriptive Information

Brief Title ^ICMJE

Pemetrexed in Patients With Advanced Neuroendocrine Tumors

Official Title ^ICMJE

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

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.
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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Neuroendocrine Tumors

Intervention ^ICMJE

Drug: Pemetrexed

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2010

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00424723

Responsible Party

Matthew Kulke, MD, Dana-Farber Cancer Institute

Study ID Numbers ^ICMJE

05-309

Study Sponsor ^ICMJE

Dana-Farber Cancer Institute

Collaborators ^ICMJE

Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Massachusetts General Hospital

Investigators ^ICMJE

Principal Investigator:

Matthew Kulke, MD

Dana-Farber Cancer Institute

Information Provided By

Dana-Farber Cancer Institute

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP