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

Overview

Información sobre este estudio

This randomized pilot 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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Aminah Jatoi, M.D.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publicaciones

Publications are currently not available
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CLS-20111740

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