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NCT00899951 Clinical Trial

Studying Fentanyl in Patients With Cancer

Pain Clinical Trial

Official title:
Pharmacokinetics of Continuous Infusion Fentanyl in Cancer Patients

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00899951
Other study ID # J06129 CDR0000600337
Secondary ID P30CA006973JHOC-
Status Terminated
Phase N/A
First received May 9, 2009
Last updated April 16, 2013
Start date October 2007
Est. completion date July 2009

Study information
Verified date April 2013
Source Sidney Kimmel Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 2
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

  • Brain and Central Nervous System Tumors
  • Central Nervous System Neoplasms
  • Chronic Myeloproliferative Disorders
  • Disease
  • Leukemia
  • Lymphoma
  • Lymphoproliferative Disorder
  • Lymphoproliferative Disorders
  • Multiple Myeloma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic-Myeloproliferative Diseases
  • Myelodysplastic/Myeloproliferative Neoplasms
  • Myeloproliferative Disorders
  • Neoplasms
  • Neoplasms, Plasma Cell
  • Nervous System Neoplasms
  • Pain
  • Plasmacytoma
  • Precancerous Condition
  • Precancerous Conditions
  • Preleukemia
  • Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• fentanyl citrate

Other:
• pharmacological study

Locations
Country Name City State
United States Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland

Sponsors (2)
Lead Sponsor Collaborator
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetics of fentanyl citrate two baseline samples, serial samples obtained at 0,4,8,24,48,72,96,168,240 hrs after discontinuing fentanyl No
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