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Pemetrexed in Patients With Advanced Neuroendocrine Tumors

This study has been completed.
Sponsor:
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

January 18, 2007
August 10, 2010
December 2005
January 2007   (final data collection date for primary outcome measure)
To assess the radiologic response rate associated with pemetrexed in patients with neuroendocrine tumors. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To assess the radiologic response rate associated with pemetrexed in patients with neuroendocrine tumors.
Complete list of historical versions of study NCT00424723 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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.
Not Provided
Not Provided
 
Pemetrexed in Patients With Advanced Neuroendocrine Tumors
A Phase II Study of Pemetrexed in Patients With Advanced Neuroendocrine Tumors

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

  • 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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neuroendocrine Tumors
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.
Not Provided
Chan JA, Zhu AX, Stuart K, Bhargava P, Earle CC, Clark JW, Casey C, Regan E, Kulke MH. Phase II study of pemetrexed in patients with advanced neuroendocrine tumors. Cancer Chemother Pharmacol. 2010 Oct;66(5):961-8. doi: 10.1007/s00280-010-1248-6. Epub 2010 Feb 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
March 2010
January 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00424723
05-309
Not Provided
Matthew Kulke, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
  • Massachusetts General Hospital
Principal Investigator: Matthew Kulke, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
August 2010

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