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Dexamethasone Regimens for Prophylaxis of Paclitaxel-associated Hypersensitivity Reaction

Information source: Rajavithi Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypersensitivity Reaction

Intervention: Intravenous Dexamethasone (Drug); Oral Dexamethasone (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Rajavithi Hospital

Official(s) and/or principal investigator(s):
Dr Marut Yanaranop, MD, Principal Investigator, Affiliation: Rajavithi Hospital

Overall contact:
Dr Marut Yanaranop, MD, Phone: 66813450015, Email: myanaran@hotmail.com

Summary

Comparison of the efficacy and side effects of intravenous and oral regimens of dexamethasone for prophylaxis of paclitaxel-associated hypersensitivity reactions in primary ovarian, fallopian tube and peritoneal cancer patients receiving first cycle of combination paclitaxel and carboplatin.

Clinical Details

Official title: Intravenous Versus Oral Regimens of Dexamethasone for Prophylaxis of Paclitaxel-associated Hypersensitivity Reaction in Primary Ovarian, Fallopian Tube and Peritoneal Cancer Patients: a Double-blind Randomized Controlled Trial

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: Incidence of Paclitaxel-Associated Hypersensitivity Reaction (P-HSRs) and severe P-HSRs (Safety endpoint)

Secondary outcome:

Incidence of side effects of dexamethasone

Incidence of other Adverse Events ( according to NCI CTCAE version 4.03)

Quality of life (QoL) (assessed by FACT-O score)

Detailed description: The consensus statements on the management of ovarian cancer recommended intravenous paclitaxel (175 mg/m2 over 3 hr) plus intravenous carboplatin (area under the curve [AUC] 5. 0-7. 5 mg/ml∙min) given every 3 weeks for six cycles for first-line chemotherapy. A major limitation of paclitaxel was its poor water solubility, which led to the use of polyoxyethylated castor oil vehicle or Cremophor® EL as diluents resulted a hypersensitivity reactions (HSRs). Initial P-HSRs generally occur within 10 minutes of the start of paclitaxel infusion and most occur with the first or second infusion. Majority of patients manifest as minor symptoms characterized by flushing and rashes but sometime life-threatening characterized by generalized urticaria, angioedema, bronchospasm and hypertension or until fatal may occur. The reaction is likely due to the release of histamine and other vasoactive substances in response to Cremophor EL. Originally, the prophylactic regimen composed of the use of an oral corticosteroid administered in two doses at 12 and 6 hours prior to paclitaxel infusion accompanied with histamine receptor H1 and H2 antagonists administered intravenously 30 minutes prior to paclitaxel infusion was found to successfully limit P-HSRs denoted as "Conventional oral prophylactic regimen". While this three-drug prophylactic regimen has been shown to be effective, it can be inconvenient for patients because the oral corticosteroid must be taken 12 and 6 hours before chemotherapy administration. If the patient forgets to take one or both pretreatment steroid doses, it is not clear whether the patient can be safely treated. This led to the experimental prophylactic regimen of one dose of intravenous dexamethasone accompanied with the H1 and H2 antagonists administered 30 minutes prior to paclitaxel infusion was subsequently reported to be equivalent to the regimen of oral dexamethasone denoted as "Modified intravenous prophylactic regimen". This intravenous regimen results in lower total steroid doses and precludes the issues of compliance.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Patient pathologically diagnosed with primary ovarian or fallopian tube or peritoneal

cancer

- Patient starting a first cycle of combination paclitaxel and carboplatin at Rajavithi

Hospital between February 1, 2015 and July 31, 2015

- Patient aged 18-70 years

- Patient with ECOG performance status 0-2

- Patient with the following laboratory values obtained: Hemoglobin > 10 g/dL, Absolute

neutrophil count > 1500 /mm3, Platelet count > 100,000/mm3, Serum creatinine > 2. 0 mg/dL, Bilirubin > 1. 5 x ULN, alkaline phosphatase and SGOT > 3 x ULN

- Patient able to give free and informed consent and who agrees to participate by

signing the consent form

- Patient able to speak and understand Thai

- Patient able to complete the quality of life questionnaire on Functional Assessment

of Cancer Therapy - Ovarian Cancer (FACT-O) Thai version 4. 0 and the personal logbook

Exclusion Criteria:

- Patient who has previously received paclitaxel or carboplatin

- Patient receiving an albumin-bound paclitaxel

- Patient who had an allergic reaction to taxanes or platinum analogues

- Patient is currently under treatment with systemic corticosteroids or has received

systemic corticosteroids or histamine antagonists during the last week

- Patient who had an allergic reaction to corticosteroid or diphenhydramine or

ranitidine

- Patient with severe intolerance to lactose

- Patient with an allergy or a severe intolerance to products containing castor oil

e. g. cyclosporine, teniposide, diazepam, propofol

Locations and Contacts

Dr Marut Yanaranop, MD, Phone: 66813450015, Email: myanaran@hotmail.com

Rajavithi Hospital, Bangkok 10400, Thailand
Additional Information

Starting date: February 2015
Last updated: January 28, 2015

Page last updated: August 23, 2015

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