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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-19

Study Completion Date

2016-11-11

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm I (auranofin)

Patients receive auranofin PO on day 2.

Group Type EXPERIMENTAL

auranofin

Intervention Type DRUG

Given PO

questionnaire administration

Intervention Type OTHER

Ancillary studies

Arm II (placebo)

Patients receive placebo PO on day 2.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Given PO

questionnaire administration

Intervention Type OTHER

Ancillary studies

Interventions

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auranofin

Given PO

Intervention Type DRUG

placebo

Given PO

Intervention Type OTHER

questionnaire administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Ridaura PLCB

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No