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Pemetrexed in Patients With Advanced Neuroendocrine Tumors

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ClinicalTrials.gov Identifier: NCT00424723
Recruitment Status : Completed
First Posted : January 19, 2007
Last Update Posted : August 12, 2010
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by:
Dana-Farber Cancer Institute

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

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Drug: Pemetrexed Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
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
Study Start Date : December 2005
Actual Primary Completion Date : January 2007
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Intervention Details:
    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.

Outcome Measures
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Primary Outcome Measures :
  1. To assess the radiologic response rate associated with pemetrexed in patients with neuroendocrine tumors. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. To perform an analysis of the biochemical response rate [ Time Frame: 2 years ]
  2. to assess the toxicity associated with pemetrexed [ Time Frame: 2 years ]
  3. and to assess the progression-free and overall survival of patients.

Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Responsible Party: Matthew Kulke, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00424723     History of Changes
Other Study ID Numbers: 05-309
First Posted: January 19, 2007    Key Record Dates
Last Update Posted: August 12, 2010
Last Verified: August 2010

Keywords provided by Dana-Farber Cancer Institute:
pemetrexed
neuroendocrine tumors
metastatic neuroendocrine tumors

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
 Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors