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

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.

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