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

• Status: Completed
• Trial end date: 2016-11-11
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Auranofin; Paclitaxel

Criteria

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