Cinical Trials Detail Page - Genesis HealthCare System - Zanesville, Ohio

Paclitaxel/Caroplatin induced Peripheral Neuropathy

The Use of Glutathinone (GSH) for Prevention of Paclitaxel/Caroplatin induced Peripheral Neuropathy: A Phase III Randomized, Double-Blind Placebo Controlled Study

Objective

Rondomization

 GSH with each dose of chemotherapy

(Taxol/CBDCA) vs. Placebo with each dose of chemotherapy (TAXOL/CBDCA)

Treatment Cycle = 21 days

Observation Cycle Length = every 3 months for one year post chemotherapy

GSH Provided

Mandatory research blood draw

Eligibility

Scheduled to undergo treatment with TAXOL at 150-200 mg/m2 and CBDCA at AUC = 5-7 every 21 or 28 days for 6 cycles for at least 3 months (90 days). Alternativley, pacitaxel can be prescribed at 80 mg/m2 weekly for at least 3 months (90 days) without break, with same CBDCA dose of AUC = 5-7 every 21 days. Additional chemotherapy agents are allowed (bevacizumab, etoposide, etc.) per physician descretion, as long as they are known to be neurotoxic. Note: Patients will idealy begin GSH therapy prior to their first dose if this chemotherapy, but must begin GSH therapy prior to their second dose of chemotherapy.

Exclusion Criteria

  1. Pre-existing hx. of peripheral neuropathy > grade 1 for any cause
  2. Prior TAXOL and/or CBDCA chemotherapy
IRB Protocol Number
NCCTG N08CA
Principal Investigator(s)
J. Phillip Kuebler

Clinical Trial Categories

  • Cancer
Sponsor(s)
Columbus Community Clinical Oncology Program
Contact
RN. Carrie Lee, RN at 740-454-5232