Studying Fentanyl in Patients With Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Myeloproliferative Disorders; Leukemia; Lymphoma; Lymphoproliferative Disorder; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Diseases; Precancerous/Nonmalignant Condition; Unspecified Adult Solid Tumor, Protocol Specific
Intervention: fentanyl citrate (Drug); pharmacological study (Other)
Phase: N/A
Status: Recruiting
Sponsored by: Sidney Kimmel Comprehensive Cancer Center Official(s) and/or principal investigator(s):
Stuart A. Grossman, MD, Principal Investigator, Affiliation: Sidney Kimmel Comprehensive Cancer Center
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.
Clinical Details
Official title: Pharmacokinetics of Continuous Infusion Fentanyl in Cancer Patients
Study design: N/A
Primary outcome: Pharmacokinetics of fentanyl citrate
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21231-2410, United States; Recruiting
Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce, Phone: 410-955-8804, Email: jhcccro@jhmi.edu
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: October 2007
Last updated: July 7, 2009
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