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Pemetrexed in Patients With Advanced Neuroendocrine Tumors
This study has been completed.
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
First received: January 18, 2007
Last updated: August 10, 2010
Last verified: August 2010
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Pemetrexed in Patients With Advanced Neuroendocrine Tumors |
Resource links provided by NLM:
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 ]
Secondary Outcome Measures:
- 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. [ Time Frame: TBD ]
| Estimated Enrollment: | 32 |
| Study Start Date: | December 2005 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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.
- 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00424723
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
Publications:
| Responsible Party: | Matthew Kulke, MD, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00424723 History of Changes |
| Other Study ID Numbers: |
05-309 |
| Study First Received: | January 18, 2007 |
| Last Updated: | August 10, 2010 |
Keywords provided by Dana-Farber Cancer Institute:
|
pemetrexed neuroendocrine tumors metastatic neuroendocrine tumors |
Additional relevant MeSH terms:
|
Neuroendocrine Tumors Carcinoid Tumor Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Adenocarcinoma |
Carcinoma Neoplasms, Glandular and Epithelial Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on August 21, 2017