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Studying Fentanyl in Patients With Cancer

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: NCT00899951
Recruitment Status : Terminated (poor accrual)
First Posted : May 12, 2009
Last Update Posted : April 18, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Tracking Information
First Submitted Date May 9, 2009
First Posted Date May 12, 2009
Last Update Posted Date April 18, 2013
Study Start Date October 2007
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 16, 2013)
Pharmacokinetics of fentanyl citrate [ Time Frame: two baseline samples, serial samples obtained at 0,4,8,24,48,72,96,168,240 hrs after discontinuing fentanyl ]
Original Primary Outcome Measures
 (submitted: May 9, 2009)
Pharmacokinetics of fentanyl citrate
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Studying Fentanyl in Patients With Cancer
Official Title Pharmacokinetics of Continuous Infusion Fentanyl in Cancer Patients
Brief Summary

RATIONALE: Studying blood samples from cancer patients undergoing pain treatment in the laboratory may help doctors learn more about how pain drugs work in the body. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at fentanyl in patients with cancer.

Detailed Description

OBJECTIVES:

  • To describe the pharmacokinetics of prolonged intravenous infusions of fentanyl citrate in adult patients with cancer.

OUTLINE: Patients undergo blood sample collection before and after discontinuation of fentanyl citrate therapy (10 days total). Pharmacokinetic analysis is performed on the samples.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population cancer pts
Condition
  • Brain and Central Nervous System Tumors
  • Chronic Myeloproliferative Disorders
  • Leukemia
  • Lymphoma
  • Lymphoproliferative Disorder
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • Pain
  • Precancerous Condition
  • Unspecified Adult Solid Tumor, Protocol Specific
Intervention
  • Drug: fentanyl citrate
  • Other: pharmacological study
Study Groups/Cohorts Cohort 1
receiving fentaly citrate
Interventions:
  • Drug: fentanyl citrate
  • Other: pharmacological study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: April 16, 2013)
2
Original Estimated Enrollment
 (submitted: May 9, 2009)
20
Actual Study Completion Date July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of cancer
  • Inpatient at the Johns Hopkins Hospital Cancer Center undergoing pain treatment with continuous infusion fentanyl citrate for ≥ 5 days

PATIENT CHARACTERISTICS:

  • Willing to change to an alternative opioid

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 72 hours since transdermal fentanyl citrate administration
  • At least 12 hours since transmucosal fentanyl citrate administration
  • No known requirement for continued opioid therapy with any fentanyl citrate products after discontinuation of fentanyl citrate therapy
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00899951
Other Study ID Numbers J06129 CDR0000600337
P30CA006973 ( U.S. NIH Grant/Contract )
JHOC-J06129
JHOC-NA-00006329
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Stuart A. Grossman, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
PRS Account Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Verification Date April 2013