Paclitaxel-induced hypersensitivity reactions
Conditions
Interventions
Trade Name: Zantac
Product Name: Ranitidine
Pharmaceutical Form: Solution for injection
INN or Proposed INN: RANITIDINE
CAS Number: 6635
Sponsors
Erasmus MC
Maasstad Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age =18 years; • Able and willing to give written informed consent; • Planned treatment with regular paclitaxel based chemotherapy for any indication and with any dose. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 189 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 365
Exclusion criteria
Exclusion criteria: • Prior treatment with a paclitaxel based regimen; • Known hypersensitivity to paclitaxel, carboplatin, docetaxel, ranitidine, dexamethasone, clemastine, granisetron, ondansetron or excipients; • Unwilling to stop the use of H2-antagonists for gastroduodenal reflux and ulcer disease. The H2-antagonist should be stopped at least two days before the first paclitaxel infusion (washout). Switching an H2-antagonist to a proton pump inhibitor is allowed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary outcome will be the percentage (%) of patients who experience an HSR CTCAE grade 3, 4 or 5 after paclitaxel infusion, grade determined prospectively by the oncology medical staff. ;Main Objective: To evaluate the incidence of clinically relevant HSRs (grade =3 as per Common Terminology Criteria for Adverse Events; CTCAE version 4.0) during paclitaxel-based chemotherapy with a standard of care premedication regimen with ranitidine compared to an experimental premedication regimen without ranitidine.; Secondary Objective: 1. To determine the severity (grade) of paclitaxel-induced HSR as defined by CTCAE (version 4.0) with and without ranitidine. 2. To determine the percentages of patients that can be rechallenged (according to standard of care) after an HSR with and without ranitidine. 3. To determine the number of paclitaxel dosages until first HSR occurrence with and without ranitidine. 4. To determine the cost-effectiveness of the premedication regimens with and without ranitidine during paclitaxel treatment. 5. To determine the cumulative dose of paclitaxel at the moment of HSR occurrence with and without ranitidine. 6. To determine the effect of the removal of ranitidine on the quality of life for patients receiving paclitaxel. ; Timepoint(s) of evaluation of this end point: Evaluation of the primary endpoint will take place when 554 patients have been included and have finished the study. Finishing the study means that a person must have experienced a hypersensitivity reaction on paclitaxel or that he/she has received the last dose of paclitaxel. An interim analysis will be performed on the primary endpoint by a DSMB when 185 (33.4%) patients are included and completed the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. To determine the severity (grade) of paclitaxel-induced HSR as defined by CTCAE (version 4.0) with and without ranitidine. 2. To determine the percentages of patients that can be rechallenged (according to standard of care) after an HSR with and without ranitidine. 3. To determine the number of paclitaxel dosages until first HSR occurrence with and without ranitidine. 4. To determine the cost-effectiveness of the premedication regimens with and without ranitidine during paclitaxel treatment. 5. To determine the cumulative dose of paclitaxel at the moment of HSR occurrence with and without ranitidine. 6. To determine the effect of the removal of ranitidine on the quality of life for patients receiving paclitaxel. ;Timepoint(s) of evaluation of this end point: End of study. | — |
Countries
Netherlands
Contacts
Public ContactJ.M. Cox
Erasmus MC
Outcome results
None listed