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

Objectives

1. 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

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

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

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