Studying Fentanyl in Patients With Cancer

NCT ID: NCT00899951

Last Updated: 2013-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

receiving fentaly citrate

fentanyl citrate

Intervention Type DRUG

pharmacological study

Intervention Type OTHER

Interventions

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fentanyl citrate

Intervention Type DRUG

pharmacological study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stuart A. Grossman, MD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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P30CA006973

Identifier Type: NIH

Identifier Source: secondary_id

View Link

JHOC-J06129

Identifier Type: -

Identifier Source: secondary_id

JHOC-NA-00006329

Identifier Type: -

Identifier Source: secondary_id

J06129 CDR0000600337

Identifier Type: -

Identifier Source: org_study_id

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