WithdrawnPhase 3

A Study of IV Casopitant for the Prevention of Nausea and Vomiting Caused By Cisplatin-Based Highly Emetogenic Chemotherapy

Stopped: This study has been cancelled prior to enrollment.

United States, Canada0Started 2009-09

Plain-language summary

This is a phase III study designed to demonstrate the superiority of single-dose 90 mg intravenous (IV) casopitant over placebo, each in combination with ondansetron and dexamethasone, for the prevention of emesis over the first 0-120 hours (overall phase) following initiation of the cisplatin infusion in the first cycle of highly emetogenic chemotherapy (HEC). Eligibility is limited to subjects who are scheduled to receive their first cycle of chemotherapy which includes at least 60 mg/m2 of cisplatin administered on Day 1 only of a 21 day or 28 day cycle. All subjects will receive IV ondansetron and oral dexamethasone on Day 1 prior to initiation of the cisplatin infusion, followed by oral dexamethasone on Days 2-4. Additionally, subjects will be randomized to receive single-dose 90 mg IV casopitant or matching placebo prior to initiation of a cisplatin-based HEC regimen.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: A subject will be considered eligible for initial inclusion in this study, and progression into subsequent cycles of therapy within the study, only if all of the following criteria apply: * Subject understands the nature and purpose of this study and the study procedures and has signed an informed consent form for this study to indicate this understanding. * At least 18 years of age. * Is scheduled to receive oxaliplatin at a dose between 85 mg/m2 and 130 mg/m2 in their first cycle of therapy for the treatment of colorectal cancer, administered as a single IV dose over 2-6 hours on Day 1 only, in combination with 5FU/LV, or in combination with capecitabine. Refer to Section 4.1 for the list of chemotherapy agents that may be added to oxaliplatin. * An Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. * Hematologic and metabolic status adequate for receiving an oxaliplatin-based moderately emetogenic regimen and meeting the following criteria: * Total Neutrophils ≥1500/mm3 (Standard units : ≥1.5 x 109/L) * Platelets ≥100,000/mm3 (Standard units: ≥100.0 x 109/L) * Bilirubin ≤1.5 x upper limit of normal (ULN) * Serum Creatinine ≤1.5 mg/dL (Standard units : ≤132.6 µmol/L) OR * Creatinine clearance ≥60 mL/min Creatinine clearance must be calculated using the Cockcroft-Gault formula: Clcreat (ml/min) = (140-age \[yr\]) x body wt \[kg\] / 72 x serum creatinine \[mg/dl\] For females: multiply creatinine clearance by a factor of 0.85. …

What they're measuring

The proportion of subjects who achieve a complete response (defined as no vomiting/retching and no rescue therapy).

Timeframe: Overall phase (0-120 hours) following initiation of the first cycle of a cisplatin-based HEC regimen.

Trial details

NCT IDNCT00891761

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-07