Studying Fentanyl in Patients With Cancer

Johns Hopkins Medicine

Status: Terminated

Conditions: Multiple Myeloma and Plasma Cell Neoplasm; Brain and Central Nervous System Tumors; Unspecified Adult Solid Tumor, Protocol Specific; Lymphoproliferative Disorder; Precancerous Condition; Chronic Myeloproliferative Disorders; Lymphoma; Leukemia; Pain; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms

Treatments: Other: pharmacological study; Drug: fentanyl citrate

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00899951

P30CA006973 (U.S. NIH Grant/Contract)

JHOC-NA-00006329

J06129 CDR0000600337

JHOC-J06129

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

2 participants in 1 patient group

Cohort 1

Description:

receiving fentaly citrate

Treatment:

Drug: fentanyl citrate

Other: pharmacological study