Studying Fentanyl in Patients With Cancer
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cohort 1 receiving fentaly citrate |
Drug: fentanyl citrate
Other: pharmacological study
|
Outcome Measures
Primary Outcome Measures
- Pharmacokinetics of fentanyl citrate [two baseline samples, serial samples obtained at 0,4,8,24,48,72,96,168,240 hrs after discontinuing fentanyl]
Eligibility Criteria
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
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No known requirement for continued opioid therapy with any fentanyl citrate products after discontinuation of fentanyl citrate therapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | United States | 21231-2410 |
Sponsors and Collaborators
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Stuart A. Grossman, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- J06129 CDR0000600337
- P30CA006973
- JHOC-J06129
- JHOC-NA-00006329