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Completed

NCT Number: NCT02776436

Reducing Dexamethasone Around Docetaxel Infusion

The manufacturer recommends two different regimens of prophylactic dexamethasone to prevent hypersensitivity and fluid retention reactions caused by docetaxel: a 3-day regime of dexamethasone 8mg twice a day starting the day before chemotherapy for breast cancer and for prostate cancer 3 times 8mg dexamethasone on the day of docetaxel infusion, given the concurrent use of prednisone 2dd5mg. There is little evidence that supports this high dose regimen used nowadays. There is need to re-evaluate this high dosage of dexamethasone for three main reasons. First, dexamethasone can give side effects such as manifestation of latent diabetes mellitus, immunosuppression, personality changes, irritability, euphoria, or mania and mood swings. Second, dexamethasone is an immune suppressor, which might inhibit chemotherapy-induced apoptosis and compromise the efficacy of chemotherapeutic agents. Third, dexamethasone is a CYP3A4 inducer, which might increase docetaxel clearance. This study aims to evaluate the feasibility of reducing prophylactic of dexamethasone around docetaxel infusion.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Reinier de Graaf hospital, Delft, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with early breast cancer, or advanced breast cancer or prostate cancer patients receiving docetaxel (minimal 3 cycles monotherapy or in the regimen 4xAC > 4xdocetaxel or 3xFEC>3xdocetaxel or 6xTAC)
  • 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 (<5 x UNL in case of liver metastases), Alkaline Phosphatase ≤5 x UNL
  • Adequate renal function: the calculated creatinine clearance should be ≥50 mL/min
  • Survival expectation must be > 3 months
  • Written informed consent according to the local Ethics Committee requirements

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

Treatment and study plan

Dexamethasone

Drug

Dose of prophylactic dexamethasone will be reduced for all patients

Other names: dexa

Prednisone

Drug

standard prednisone 5 mg bid for patients with prostate cancer

Other names: prednison

Primary outcomes

  1. Optimal dose/recommended dose (RD) of pre-medication dexamethasone around docetaxel infusion, dependent of occurrence of grade III/IV fluid retention and HSR according to the NCI CTCAE v4.03.

    Time frame: up to 30 weeks

    If one grade III/IV HSR or fluid retention reaction occurs in one of the six patients within one cohort, then three additional patients will be treated at that dose level. If there are no additional grade III/IV HSR or fluid retention in that additional 3 patients accrual to the next lower dose level will be started. If a grade III/IV HSR or fluid retention occurs in at least 2/6 or 2/9 patients, that dose will not be tolerated as safe and the last previous dose level of dexamethasone will be the RD.

Secondary outcomes

  1. Glucose (mmol/L) response due to prophylactic dexamethasone on day 0 before chemotherapy.

    Time frame: up to 30 weeks

  2. Insulin(mU/L), response due to prophylactic dexamethasone on day 0 before chemotherapy.

    Time frame: up to 30 weeks

  3. IGF-1(nmol/L) response due to prophylactic dexamethasone on day 0 before chemotherapy.

    Time frame: up to 30 weeks

  4. Number of participants with toxicity of chemotherapy according to NCI CTCAE v4.03 compared in each dose level of dexamethasone.

    Time frame: up to 30 weeks

  5. Patient's quality of life (descriptive).

    Time frame: up to 30 weeks

  6. Number of patients with single nucleotide polymorphisms in the glucocorticoid receptor.

    Time frame: one week

Other outcomes

  1. The effect of dexamethasone on the Maximum concentration of docetaxel (Cmax)

    Time frame: 24 hours

  2. The effect of dexamethasone on Area under the plasma-time concentration curve (AUC) of docetaxel.

    Time frame: 24 hours

  3. The effect of dexamethasone on Elimination half-lives of docetaxel (T½,α; T½,β; T½,ƴ) of docetaxel.

    Time frame: 24 hours

  4. The effect of dexamethasone on Total body clearance of docetaxel (Cl) of docetaxel.

    Time frame: 24 hours

  5. The effect of dexamethasone on Volume of distribution of docetaxel at steady state (Vdss)

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Registry information

Official study title

Phase 1 Study to Evaluate the Safety of REducing the Prophylactic Dose of DEXamethasone Around Docetaxel Infusion in Patients With Early or Advanced Breast Cancer and Prostate Cancer

Acronym: REDEX

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
May 18, 2016
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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