Auranofin in Decreasing Pain in Patients With Paclitaxel-Induced Pain Syndrome

Completed · Phase 2 · Has a placebo group

Conditions studied: Pain

In brief

This randomized pilot clinical trial studies whether auranofin will relieve pain following paclitaxel in patients who have previously experienced paclitaxel-induced pain. Auranofin is a drug given by mouth to treat other diseases such as rheumatoid arthritis, and is being studied to see if it will decrease pain following paclitaxel.

Key facts

Study ID

NCT02063698

Run by

Mayo Clinic

People needed

30

Starts

2014-02-19

Expected to finish

2016-11-11

Last updated by the study team

2019-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Absolute neutrophil count (ANC) >= 1500/mm\^3
• Platelet count (PLT) >= 100,000/mm\^3
• Creatinine =< 2 x upper limit of normal (ULN)
• Either serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) or serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 1.5 x ULN
• Total/direct bilirubin =< 1.5 x ULN
• Alkaline phosphatase =< 1.5 x ULN
• Hemoglobin >= 9 mg/dL
• Negative urine or serum pregnancy test performed =< 7 days prior to registration, for women of childbearing potential only
• Previously experienced paclitaxel induced pain during a current or past paclitaxel treatment that the treating healthcare provider thinks is consistent with the paclitaxel-induced acute pain syndrome; note: formal documentation of prior pain is not required
• Scheduled to receive paclitaxel at a dose >= 70 mg/m\^2 =< 14 days from randomization
• Ability to complete the questionnaires or to do so with assistance

You may not qualify if…

• Pregnant women
• Nursing women
• Any woman of childbearing potential or male partner of a woman of childbearing potential unwilling to employ acceptable contraception throughout the study and for at least 30 days after the last dose of the study drug
• History of gold-induced disorders, including but not limited to, necrotizing enterocolitis, pulmonary fibrosis, exfoliative dermatitis, bone marrow aplasias or other severe hematologic disorders; history of severe allergic or anaphylactic reactions or hypersensitivity to auranofin or other gold compounds
• Currently receiving Dilantin (phenytoin) or auranofin or another gold-containing compound
• Anticipated use of filgrastim (G-CSF) or sargramostim (GM-CSF) within 30 days after receiving auranofin
• Currently receiving immune-modulating therapies

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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