Status:
COMPLETED
Safely Stopping Pre-medications in Patients With Breast Cancer Who Are Receiving Paclitaxel
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
Anatomic Stage 0 Breast Cancer AJCC v8
Anatomic Stage I Breast Cancer AJCC v8
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This phase II/III trial investigates the difference in rates of infusion hypersensitivity reaction in patients with breast cancer who are receiving paclitaxel alone or in combination with other cancer...
Detailed Description
PRIMARY OBJECTIVE: I. To estimate the difference in rates of infusion hypersensitivity reaction (HSR) requiring parenteral rescue medications following the discontinuation of pre-medications after 2 ...
Eligibility Criteria
Inclusion
- Patients scheduled to receive at least 4 doses of paclitaxel as a single-agent or in combination with trastuzumab, pertuzumab, bevacizumab, pembrolizumab, lapatinib, gemcitabine or other drug combination (excluding cisplatin or carboplatin) for the treatment of any stage, histologically confirmed breast cancer
- Ability to complete questionnaires by themselves or with assistance
- Life expectancy \> 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Age \>= 18
- Able to give informed consent
- Patients must be scheduled to receive prophylactic HSR premedications (IV or oral) consisting of a histamine-1 (H1) antagonist (diphenhydramine) or cetirizine (a histamine-1 (H1) antagonists), dexamethasone (a steroid) and a either famotidine, ranitidine or cimetidine (histamine-2 (H2) antagonists), per institutional guidelines, prior to each of their first 2 doses of paclitaxel
- Patients may enroll, or currently be enrolled in another concurrent clinical trial provided the other trial would not prohibit the discontinuation of paclitaxel premedications
Exclusion
- Patients who have received at least 1 prior lifetime dose of paclitaxel or paclitaxel albumin-bound
- Patients receiving paclitaxel in combination with carboplatin or cisplatin (due to risk of hypersensitivity with platinum compounds)
- History of grade 3 hypersensitivity reaction to Cremophor EL containing medications (e.g. paclitaxel, cyclosporine, ixabepilone, teniposide)
- Patients receiving therapeutic daily doses of systemic corticosteroids. Intermittent oral steroids for nausea or for acute inflammatory conditions (i.e. methylprednisolone dosepak) and inhaled, intranasal or topical corticosteroids are permitted
- Patients who are pregnant or nursing. Paclitaxel is classified by the Food and Drug Administration (FDA) as "pregnancy category D". Pregnancy testing (urine or blood human chorionic gonadotropin \[Hcg\]) will be done and documented prior to enrollment if pregnancy is clinically suspected
Key Trial Info
Start Date :
October 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2024
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04862585
Start Date
October 7 2021
End Date
June 21 2024
Last Update
August 20 2025
Active Locations (1)
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1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210