Studying Fentanyl in Patients With Cancer
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ClinicalTrials.gov Identifier: NCT00899951 |
Recruitment Status
:
Terminated
(poor accrual)
First Posted
: May 12, 2009
Last Update Posted
: April 18, 2013
|
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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 |
---|---|
Brain and Central Nervous System Tumors Chronic Myeloproliferative Disorders Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Pain Precancerous Condition Unspecified Adult Solid Tumor, Protocol Specific | Drug: fentanyl citrate Other: pharmacological study |
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 Type : | Observational |
Actual Enrollment : | 2 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Pharmacokinetics of Continuous Infusion Fentanyl in Cancer Patients |
Study Start Date : | October 2007 |
Actual Primary Completion Date : | July 2009 |
Actual Study Completion Date : | July 2009 |

Group/Cohort | Intervention/treatment |
---|---|
Cohort 1
receiving fentaly citrate
|
Drug: fentanyl citrate Other: pharmacological study |
- Pharmacokinetics of fentanyl citrate [ Time Frame: two baseline samples, serial samples obtained at 0,4,8,24,48,72,96,168,240 hrs after discontinuing fentanyl ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00899951
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231-2410 |
Principal Investigator: | Stuart A. Grossman, MD | Sidney Kimmel Comprehensive Cancer Center |
Responsible Party: | Sidney Kimmel Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00899951 History of Changes |
Other Study ID Numbers: |
J06129 CDR0000600337 P30CA006973 ( U.S. NIH Grant/Contract ) JHOC-J06129 JHOC-NA-00006329 |
First Posted: | May 12, 2009 Key Record Dates |
Last Update Posted: | April 18, 2013 |
Last Verified: | April 2013 |
Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
unspecified adult solid tumor, protocol specific accelerated phase chronic myelogenous leukemia acute undifferentiated leukemia adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) atypical chronic myeloid leukemia, BCR-ABL1 negative blastic phase chronic myelogenous leukemia chronic myelomonocytic leukemia chronic phase chronic myelogenous leukemia mast cell leukemia |
meningeal chronic myelogenous leukemia progressive hairy cell leukemia, initial treatment prolymphocytic leukemia recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia recurrent adult T-cell leukemia/lymphoma refractory chronic lymphocytic leukemia refractory hairy cell leukemia relapsing chronic myelogenous leukemia secondary acute myeloid leukemia stage 0 chronic lymphocytic leukemia stage I adult T-cell leukemia/lymphoma stage I chronic lymphocytic leukemia stage II adult T-cell leukemia/lymphoma stage II chronic lymphocytic leukemia |
Additional relevant MeSH terms:
Lymphoma Disease Syndrome Leukemia Neoplasms Multiple Myeloma Neoplasms, Plasma Cell Myelodysplastic Syndromes Preleukemia Nervous System Neoplasms Central Nervous System Neoplasms Myeloproliferative Disorders Plasmacytoma Lymphoproliferative Disorders Myelodysplastic-Myeloproliferative Diseases |
Precancerous Conditions Neoplasms by Histologic Type Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Pathologic Processes Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases Neoplasms by Site |