Pemetrexed in Patients With Advanced Neuroendocrine Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00424723|
Recruitment Status : Completed
First Posted : January 19, 2007
Last Update Posted : August 12, 2010
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors||Drug: Pemetrexed||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Pemetrexed in Patients With Advanced Neuroendocrine Tumors|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||January 2007|
|Actual Study Completion Date :||March 2010|
- Drug: Pemetrexed
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.
- To assess the radiologic response rate associated with pemetrexed in patients with neuroendocrine tumors. [ Time Frame: 2 years ]
- To perform an analysis of the biochemical response rate [ Time Frame: 2 years ]
- to assess the toxicity associated with pemetrexed [ Time Frame: 2 years ]
- and to assess the progression-free and overall survival of patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00424723
|United States, Massachusetts|
|Dana-Farber Cancer Center|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Matthew Kulke, MD||Dana-Farber Cancer Institute|