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Pharmacokinetics of Continuous Infusion Fentanyl in Cancer Patients


N/A
18 Years
N/A
Not Enrolling
Both
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

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Trial Information

Pharmacokinetics of Continuous Infusion Fentanyl in Cancer Patients


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.

Inclusion 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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Pharmacokinetics of fentanyl citrate

Outcome Time Frame:

two baseline samples, serial samples obtained at 0,4,8,24,48,72,96,168,240 hrs after discontinuing fentanyl

Safety Issue:

No

Principal Investigator

Stuart A. Grossman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

J06129 CDR0000600337

NCT ID:

NCT00899951

Start Date:

October 2007

Completion Date:

July 2009

Related Keywords:

  • 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
  • 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
  • stage III adult T-cell leukemia/lymphoma
  • stage III chronic lymphocytic leukemia
  • stage IV adult T-cell leukemia/lymphoma
  • stage IV chronic lymphocytic leukemia
  • T-cell large granular lymphocyte leukemia
  • recurrent adult Hodgkin lymphoma
  • stage I adult Hodgkin lymphoma
  • stage II adult Hodgkin lymphoma
  • stage III adult Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • anaplastic large cell lymphoma
  • angioimmunoblastic T-cell lymphoma
  • cutaneous B-cell non-Hodgkin lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • stage I cutaneous T-cell non-Hodgkin lymphoma
  • stage II cutaneous T-cell non-Hodgkin lymphoma
  • stage III cutaneous T-cell non-Hodgkin lymphoma
  • stage IV cutaneous T-cell non-Hodgkin lymphoma
  • recurrent mycosis fungoides/Sezary syndrome
  • stage I mycosis fungoides/Sezary syndrome
  • stage II mycosis fungoides/Sezary syndrome
  • stage III mycosis fungoides/Sezary syndrome
  • stage IV mycosis fungoides/Sezary syndrome
  • adult grade III lymphomatoid granulomatosis
  • adult nasal type extranodal NK/T-cell lymphoma
  • Waldenström macroglobulinemia
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • contiguous stage II adult Burkitt lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • contiguous stage II adult diffuse mixed cell lymphoma
  • contiguous stage II adult diffuse small cleaved cell lymphoma
  • contiguous stage II adult immunoblastic large cell lymphoma
  • contiguous stage II adult lymphoblastic lymphoma
  • contiguous stage II grade 1 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • contiguous stage II mantle cell lymphoma
  • contiguous stage II marginal zone lymphoma
  • contiguous stage II small lymphocytic lymphoma
  • stage I adult Burkitt lymphoma
  • stage I adult diffuse large cell lymphoma
  • stage I adult diffuse mixed cell lymphoma
  • stage I adult diffuse small cleaved cell lymphoma
  • stage I adult immunoblastic large cell lymphoma
  • stage I adult lymphoblastic lymphoma
  • stage I grade 1 follicular lymphoma
  • stage I grade 2 follicular lymphoma
  • stage I grade 3 follicular lymphoma
  • stage I mantle cell lymphoma
  • stage I marginal zone lymphoma
  • stage I small lymphocytic lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult diffuse small cleaved cell lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • stage III adult Burkitt lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III mantle cell lymphoma
  • stage III marginal zone lymphoma
  • stage III small lymphocytic lymphoma
  • stage IV adult Burkitt lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV mantle cell lymphoma
  • stage IV marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult grade III lymphomatoid granulomatosis
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • intraocular lymphoma
  • primary central nervous system non-Hodgkin lymphoma
  • primary central nervous system Hodgkin lymphoma
  • post-transplant lymphoproliferative disorder
  • chronic eosinophilic leukemia
  • chronic neutrophilic leukemia
  • primary myelofibrosis
  • essential thrombocythemia
  • polycythemia vera
  • extramedullary plasmacytoma
  • isolated plasmacytoma of bone
  • monoclonal gammopathy of undetermined significance
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • primary systemic amyloidosis
  • refractory multiple myeloma
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • myelodysplastic/myeloproliferative neoplasm, unclassifiable
  • pain
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoproliferative Disorders
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Nervous System Neoplasms
  • Precancerous Conditions
  • Lymphoma, Large-Cell, Immunoblastic
  • Central Nervous System Neoplasms
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410