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Antimitotic Agent
Stopping Pre-medications with Paclitaxel for Breast Cancer
Phase 2 & 3
Recruiting
Led By Michael J Berger, Pharm.D.
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients scheduled to receive at least 4 doses of paclitaxel as a single-agent or in combination with specified drugs for the treatment of any stage, histologically confirmed breast cancer
Patients must be scheduled to receive prophylactic HSR premedications (IV or oral) per institutional guidelines, prior to each of their first 2 doses of paclitaxel
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights
Study Summary
This trial is investigating whether it is safe to stop giving certain pre-medications to patients receiving paclitaxel for breast cancer, compared to continuing premedications.
Who is the study for?
This trial is for adults with any stage of breast cancer who are scheduled to receive at least 4 doses of paclitaxel, can consent, and have an ECOG status of 0-2. They must not be pregnant or nursing, have had prior paclitaxel treatments, daily steroid use, or a severe reaction to Cremophor EL medications.Check my eligibility
What is being tested?
The study compares the effects on patients receiving paclitaxel alone or with other drugs without standard pre-medications (like dexamethasone) against those continuing them. The goal is to see if stopping these meds reduces side effects without increasing hypersensitivity reactions.See study design
What are the potential side effects?
Paclitaxel's pre-medications may cause insomnia, gastritis, fluid retention, weight gain, mood changes and immune suppression. This trial aims to find ways to avoid these by potentially discontinuing such premedications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for at least 4 doses of paclitaxel for my breast cancer.
Select...
I am scheduled to receive medication to prevent allergic reactions before my first 2 doses of paclitaxel.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients with grade 2 or greater reactions that require parenteral rescue medications to treat an infusion hypersensitivity reaction (HSR) after the first 2 doses of paclitaxel with or without continued premedication dosing
Secondary outcome measures
Correlation between abbreviated premedication regimen results to quality of life (QoL)
Other outcome measures
Differences in a number of symptoms that might be improved, or worsened, by the hypersensitivity prevention drugs
Patient outcomes
Reaction rate
+3 moreSide effects data
From 2014 Phase 4 trial • 32 Patients • NCT0130172959%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (paclitaxel)Experimental Treatment2 Interventions
Patients discontinue premedications (dexamethasone, diphenhydramine, famotidine/ranitidine/cimetidine) with all future doses of paclitaxel, unless patient develops a subsequent infusion HSR.
Group II: Arm I (paclitaxel, pre-medications)Active Control7 Interventions
Patients continue on pre-medications (dexamethasone, diphenhydramine, famotidine/ranitidine/cimetidine) with all future doses of paclitaxel.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Find a Location
Who is running the clinical trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
320 Previous Clinical Trials
290,037 Total Patients Enrolled
22 Trials studying Breast Cancer
2,884 Patients Enrolled for Breast Cancer
Michael J Berger, Pharm.D.Principal InvestigatorOhio State University Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for at least 4 doses of paclitaxel for my breast cancer.I have received paclitaxel or its albumin-bound form before.You are expected to live for more than 6 months.I am in another trial but it allows stopping paclitaxel premeds.I am not pregnant or nursing, as I understand the treatment could harm my baby.I am scheduled to receive medication to prevent allergic reactions before my first 2 doses of paclitaxel.I can take care of myself and am up and about more than half of my waking hours.I am 18 years old or older.I am currently being treated with paclitaxel and either carboplatin or cisplatin.I am taking daily medication that includes steroids.You have had a severe allergic reaction to medications containing Cremophor EL.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (paclitaxel)
- Group 2: Arm I (paclitaxel, pre-medications)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What maladies does Paclitaxel commonly address?
"Paclitaxel is a medication used to duodenum. It can also effectively treat central retinal vein occlusion (crvo), seborrheic dermatitis, and hypersensitivity."
Answered by AI
How many people are recruited in total for this experiment?
"That is accurate. The clinical trial, which was first announced on October 7th 2021, is currently recruiting patients according to data available on clinicaltrials.gov. They are looking for 100 individuals across 1 site."
Answered by AI
Are researchers looking for more participants in this clinical trial?
"The clinicaltrial.gov website verifies that this study is still looking for participants and has been doing so since October 7th, 2021. The 100 patients will be recruited from a single location."
Answered by AI
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