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

Mayo Clinic

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Other: placebo; Other: questionnaire administration; Drug: auranofin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02063698

P30CA015083 (U.S. NIH Grant/Contract)

NCI-2014-00165 (Registry Identifier)

MC1364 (Other Identifier)

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

I. Determine whether one dose of auranofin given the day following administration of paclitaxel decreases pain as assessed by daily completion of the Modified Brief Pain Inventory scale for seven days.

SECONDARY OBJECTIVES:

I. Assess whether auranofin is well tolerated in this setting.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive auranofin orally (PO) on day 2.

ARM II: Patients receive placebo PO on day 2.

After completion of study treatment, patients are followed up at 21-28 days.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Arm I (auranofin)

Experimental group

Description:

Patients receive auranofin PO on day 2.

Treatment:

Drug: auranofin

Other: questionnaire administration

Arm II (placebo)

Placebo Comparator group

Description:

Patients receive placebo PO on day 2.

Treatment:

Other: questionnaire administration

Other: placebo