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

NCT02063698 | Completed Phase 2 Results DMC

• 3 other identifiers: MC1364NCI-2014-00165P30CA015083
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Outcome Measures

Primary Outcomes (2)

• Count/Percentage of Patients Who Report Having Experienced the Paclitaxel-induced Pain Syndrome (PIAPS) for One Week After Paclitaxel After Enrollment to the Current Trial, Assessed by the Modified Brief Pain Inventory Scale (BPI)

  The primary endpoint is the per arm count/percentage of patients who report having experienced the PIAPS for one week after paclitaxel after enrollment to the current trial. Pain was assessed on the question 'Please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours'. The count of participants who report having experienced the PIAPS for one week after paclitaxel after enrollment to the current trial circling 'less than 4' and 'greater than or equal to 4' for each day between day 2 to day 8 are reported below. Modified Brief Pain Inventory (BPI) ranges from 0 to 10, with higher scores corresponding to more /worse pain. Fisher's Exact Test will be used to compare the frequency of patients who experienced PIAPS between the two arms.

  Up to 28 days

• Area Under the Curve (AUC) Summary of Worst Pain in the Last 24 Hours From Days 2 to 8

  Area under the curve (AUC) Summary of Worst Pain in the last 24 hours from days 2 to 8. On a scale of 0-100, with 100=Best QOL. Pain was assessed on the question 'Please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours.' Modified Brief Pain Inventory (BPI) ranges from 0 to 10, with higher scores corresponding to more pain. The AUC for this question was then calculated and ranged from 0-100, with higher scores corresponding to less/improved pain. The Equal Variance T-test will be used to compare the average AUC for worst pain between the two arms.

  Up to 8 days

Secondary Outcomes (7)

• Normalized AUC for BPI Average Pain From the Modified BPI in the Last 24 Hours From Days 2 to 8

  Up to 28 days

• Worst Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4

  Up to 28 days

• Cramp Pain as Measured by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 5

  Up to 5 days

• Gnawing Pain as Measure by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 8

  Up to 8 days

• Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Upper Arm Pain

  Up to 5 days

Study Arms (2)

Arm I (auranofin)

EXPERIMENTAL

Patients receive auranofin PO on day 2.

Drug: auranofin; Other: questionnaire administration

Arm II (placebo)

PLACEBO COMPARATOR

Patients receive placebo PO on day 2.

Other: placebo; Other: questionnaire administration

Interventions

auranofin DRUG

Given PO

Also known as: Ridaura

Arm I (auranofin)

placebo OTHER

Given PO

Also known as: PLCB

Arm II (placebo)

questionnaire administration OTHER

Ancillary studies

Arm I (auranofin); Arm II (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Auranofin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aurothioglucose; Organogold Compounds; Organometallic Compounds; Organic Chemicals

Results Point of Contact

• Title: Aminah Jatoi, MD
• Organization: Mayo Clinic

Jatoi.Aminah@mayo.edu

(507) 284-7202

Study Officials

• Aminah Jatoi

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: February 14, 2014
• Study Start: February 19, 2014
• Primary Completion: November 11, 2015
• Study Completion: November 11, 2016
• Last Updated: April 23, 2019
• Results First Posted: April 23, 2019

Record last verified: 2018-12

Locations

US (1)