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Preventing Nerve Damage Induced by Chemotherapy

ABSTRACT: Interventions: Calcium 1 gm/10 mL and magnesium 1gm/2mL administered simultaneously , or placebo of 5% Dextrose 12mL intravenous infusion, given over 20 minutes, prior to and after chemotherapy on Day1 Cycle 1 and then 21 days later on Day 1 Cycle 2 Primary outcome(s): Intact Oxaliplatin parameters. A HPLC-tandem mass spectrometry method was developed and validated for the quantitation of intact oxaliplatin in human plasma[13 samples during Day 1 of each of Cycle 1 and Cycle 2 at pre treatment and 20, 40, 60, 90mins during oxaliplatin infusion, end of infusion and 5, 10, 20, 30, 60, 120, 180 minutes after the end of oxaliplatin infusion] Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Crossover;Type of endpoint: Pharmacokinetics / pharmacodynamics

DISEASE(S): Neurological-other Neurological Disorders,Colorectal Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Oxaliplatin Induced Neurotoxicity,Peripheral Neuropathy

PROVIDER: 2457191 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: Subjects will be randomly allocated to blinded treatment with cimetidine during cycle one of oxaliplatin treatment then crossover to placebo treatment in cycle two, or will receive the same blinded treatments in the opposite sequence. Cimetidine or placebo capsules will be given as a single oral dose 0.5 hours prior to commencement of the oxaliplatin infusion. In the dose-escalation phase of the trial, the dose of cimetidine will be increased sequentially in cohorts of three patients using a traditional 3+3+3 rule-based oncology phase I clinical trial design. The dose escalation phase of the trial will explore cimetidine treatment given concurrently with oxaliplatin at six dose-levels (200, 400, 800, 1200, 1600 and 2000 mg). Following treatment of the first cohort of three patients at a given dose-level, three main possibilities exist: 1) if all three patients have DLT, then that dose-level will be declared the MTD and the next cohort of three patients will be treated at the next lowest dose-level; 2) if none of three patients have DLT, then the next cohort of three patients will be treated with the next highest dose level, and; 3) if one or two of three patients had DLT, then the next cohort of three patients will be treated at the same dose-level to expand that dose level. Dose escalation may stop when one or more of the following has occurred: 1) the maximally tolerated dose of cimetidine is reached; 2) cimetidine was found to significantly alter the pharmacokinetics of oxaliplatin, or; 3) the recommended dose for cohort expansion of cimetidine has been reached. After identifying a cimetidine dose recommended for cohort expansion, 30 patients will be recruited to receive a fixed dose of cimetidine using the crossover design to generate clinical p Primary outcome(s): Plasma pharmacokinetics of intact oxaliplatin defined by plasma concentration at steady-state (Css) and area under the plasma concentration-versus-time curve (AUC) of intact oxaliplatin [Single plasma sample will be collected and processed at the end of infusion on Day 1 of Cycles 1 and 2 for the main study. For the optional sub-study, 16 plasma samples will be collected at pre-infusion, at 20, 40, 60 and 90 minutes after the start of the oxaliplatin infusion, at the end of the infusion and 5, 10, 20, 30, 60, 120, 180, 300 minutes, 24 and 72 hours, thereafter.] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial

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Preventing Nerve Damage Induced by Chemotherapy

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