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Studying Fentanyl in Patients With Cancer

This study has been terminated.
(poor accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00899951
First received: May 9, 2009
Last updated: April 16, 2013
Last verified: April 2013

May 9, 2009
April 16, 2013
October 2007
July 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Pharmacokinetics of fentanyl citrate [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00899951 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Studying Fentanyl in Patients With Cancer
Pharmacokinetics of Continuous Infusion Fentanyl in Cancer Patients

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

cancer pts

  • 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
  • Drug: fentanyl citrate
  • Other: pharmacological study
Cohort 1
receiving fentaly citrate
Interventions:
  • Drug: fentanyl citrate
  • Other: pharmacological study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00899951
J06129 CDR0000600337, P30CA006973, JHOC-J06129, JHOC-NA-00006329
Yes
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Stuart A. Grossman, MD Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
April 2013

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