cancer carcinoma
Conditions
Interventions
Dose of prophylactic dexamethasone will be reduced as follows:
* EBC and ABC:
STEP 1*: 12 mg dexamethasone per day (8-4mg/day) for 3 days starting 1 day
before administration. (n=6)
STEP 2*: 8mg de
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with early breast cancer, or advanced breast cancer or prostate cancer patients receiving docetaxel (minimal 3 cycles monotherapy or in a combination regimenl) * Age *18 years * WHO performance status 0-2 * Adequate bone marrow function: white blood cells (WBCs) *3.0 x 109/l, neutrophils *1.5 x 109/l, platelets *100 x 109/l * Adequate liver function: bilirubin *1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT *2.5 x UNL ( 3 months * Written informed consent according to the local Ethics Committee requirements
Exclusion criteria
Exclusion criteria: Known hypersensitivity for docetaxel, paclitaxel or other chemotherapeutic agent or products containing polysorbate 80 or an earlier experience of anaphylaxis for food, insect bites, medication or another foreign substance. * Existence of edema of the limbs or trunk or elsewhere localized. * Active second malignancy * Diabetes Mellitus * Serious other diseases such as recent myocardial infarction (last 6 months), clinical signs of cardiac failure or clinically significant arrhythmias * Female patients who are pregnant or breast-feeding * Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary: * To measure metabolic response (glucose, insulin, IGF-1) prophylactic dexamethasone on day 0 before chemotherapy. * To determine the effect of reducing dexamethasone dose on toxicity of chemotherapy according to NCI CTCAE v4.03. * Patient*s quality of life (descriptive). * To determine single nucleotide polymorphisms in glucocorticoid receptor to predict metabolic response (glucose, insulin, IGF-1) and side effects. Side study: * To measure the effect of dexamethasone on the pharmacokinetics of docetaxel. | — |
Primary
| Measure | Time frame |
|---|---|
| Primary: To determine the optimal dose/RD of prophylactic dexamethasone around docetaxel infusion, dependent of occurrence of fluid retention and hypersensitivity reaction, grade III/IV toxicity according to the National Cancer Institute Common Terminology Criteria for Adverse Events version (NCI CTCAE) v4.03. | — |
Countries
Netherlands
Outcome results
None listed