Safely Stopping Pre-medications in Patients With Breast Cancer Who Are Receiving Paclitaxel

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 drugs which require parenteral rescue medication after stopping standard pre-medications (dexamethasone, diphenhydramine, famotidine/cimetidine/ranitidine), compared to continuing premedications. Paclitaxel is a drug used to treat breast cancer, ovarian cancer, and autoimmune deficiency syndrome (AIDS)-related Kaposi sarcoma. It blocks cell growth by stopping cell division and may kill cancer cells. It is a type of antimitotic agent. However, there are side-effects and toxicities associated with repeat exposure to this pre-medication regimen. With prolonged use of paclitaxel, especially during weekly regimens, patients are exposed to repeat doses of drugs that prevent hypersensitivity reactions. Side effects include, but are not limited to, insomnia, gastritis, fluid retention, weight gain, mood changes and immune suppression. The information gained from this study may positively influence clinical practice and help researchers develop methods to safely stop pre-medications.

Conditions

• Anatomic Stage 0 Breast Cancer AJCC v8
• Anatomic Stage I Breast Cancer AJCC v8
• Anatomic Stage IA Breast Cancer AJCC v8
• Anatomic Stage IB Breast Cancer AJCC v8
• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage IIA Breast Cancer AJCC v8
• Anatomic Stage IIB Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8
• Anatomic Stage IIIA Breast Cancer AJCC v8
• Anatomic Stage IIIB Breast Cancer AJCC v8
• Anatomic Stage IIIC Breast Cancer AJCC v8
• Anatomic Stage IV Breast Cancer AJCC v8
• Breast Carcinoma
• Prognostic Stage 0 Breast Cancer AJCC v8
• Prognostic Stage I Breast Cancer AJCC v8
• Prognostic Stage IA Breast Cancer AJCC v8
• Prognostic Stage IB Breast Cancer AJCC v8
• Prognostic Stage II Breast Cancer AJCC v8
• Prognostic Stage IIA Breast Cancer AJCC v8
• Prognostic Stage IIB Breast Cancer AJCC v8
• Prognostic Stage III Breast Cancer AJCC v8
• Prognostic Stage IIIA Breast Cancer AJCC v8
• Prognostic Stage IIIB Breast Cancer AJCC v8
• Prognostic Stage IIIC Breast Cancer AJCC v8
• Prognostic Stage IV Breast Cancer AJCC v8

Interventions

DRUG

Cimetidine

Given IV and/or PO

DRUG

Dexamethasone

Given IV and/or PO

DRUG

Diphenhydramine

Given IV and/or PO

DRUG

Famotidine

Given IV and/or PO

DRUG

Paclitaxel

Weekly or every 14 day dosing

OTHER

Quality-of-Life Assessment

Ancillary studies

DRUG

Ranitidine

Given IV and/or PO

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Michael J Berger, Pharm.D. · Ohio State University Comprehensive Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-07

Primary Completion

2024-06-21

Completion

2024-06-21

FDA Drug

Yes

Countries

• United States

Study Locations