Dexamethasone Regimens for Prophylaxis of Paclitaxel-associated Hypersensitivity Reaction

• Status: Completed
• Trial end date: 2015-08-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rajavithi Hospital
• Collaborator: Chulalongkorn University
• Treatments: Albumin-Bound Paclitaxel; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Paclitaxel

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