Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 12 of 863 for:    Advanced | Neuroendocrine Tumors

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
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by:
Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE January 18, 2007
First Posted Date  ICMJE January 19, 2007
Last Update Posted Date August 12, 2010
Study Start Date  ICMJE December 2005
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2007)
To assess the radiologic response rate associated with pemetrexed in patients with neuroendocrine tumors. [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 18, 2007)
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
 (submitted: December 19, 2007)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2007)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuroendocrine Tumors
Intervention  ICMJE 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.
Study Arms  ICMJE Not Provided
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 18, 2007)
32
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2010
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00424723
Other Study ID Numbers  ICMJE 05-309
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Matthew Kulke, MD, Dana-Farber Cancer Institute
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
PRS Account Dana-Farber Cancer Institute
Verification Date August 2010

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