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Study of Fentanyl Citrate Pharmacokinetics in Patients With Cancer

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Studying Fentanyl in Patients With Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
No phase specified Biomarker/Laboratory analysis Active Adult NCI JHOC-J06129
J06129, JHOC-NA-00006329, NCT00899951

Objectives

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

Entry 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

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

Patient Characteristics:

Willing to change to an alternative opioid

Expected Enrollment

Outcomes

Primary Outcome(s)

Pharmacokinetics of fentanyl citrate

Outline

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

Trial Contact Information

Trial Lead Organizations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Stuart Grossman, MD, Principal investigator
Ph: 410-955-8837
Email: Grossman@jhmi.edu

Trial Sites

U.S.A.

Maryland

Baltimore

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Ph: 410-955-8804

Email: jhcccro@jhmi.edu

Registry Information

Official Title		Pharmacokinetics of continuous infusion fentanyl in cancer patients

Trial Start Date		2007-10-15

Trial Completion Date		2009-03-31 (estimated)

Registered in ClinicalTrials.gov		NCT00899951

Date Submitted to PDQ		2008-07-21

Information Last Verified		2009-07-05

NCI Grant/Contract Number		CA06973

Note: The purpose of some clinical studies is to help researchers learn more about how cancer cells grow and how drugs are used in the body. Cells and tissues collected from cancer patients may be used to detect new biomarkers that may be important in diagnosing and treating cancer in the future. The procedure or lab test described in this clinical study is intended to be carried out by clinical oncologists and researchers in carefully structured settings. Individual results obtained from these studies may not be made available to patients.