docetaxel + placebo

The term "docetaxel + placebo" refers to a treatment regimen used in clinical trials as a control arm, where patients receive the chemotherapy drug docetaxel along with a placebo (instead of an experimental agent). This combination is frequently used as the comparator arm in randomized controlled trials evaluating new combination therapies for cancer, particularly metastatic castration-resistant prostate cancer (mCRPC). ## Administration Details Docetaxel in these trials is typically administered intravenously at a dose of 75 mg/m² on day 1 of each 21-day cycle[3][6]. The treatment is usually given in combination with steroids: - Dexamethasone 8 mg orally (12, 3, and 1 hour before each docetaxel infusion) - Prednisone/prednisolone 5 mg orally twice daily on each day of the 21-day cycle[6] The placebo component is administered to match the experimental drug in the active treatment arm. For example, in trials studying zibotentan, patients received placebo tablets that matched zibotentan's appearance[6]. In the capivasertib trial, placebo was given orally on an intermittent weekly dosing schedule (Days 2-5, 9-12, and 16-19 in each 21-day treatment cycle)[3]. ## Clinical Trials Several phase III clinical trials have used docetaxel + placebo as the control arm: 1. **ENTHUSE Program**: A randomized, double-blind, placebo-controlled phase III study comparing docetaxel plus zibotentan 10 mg/day versus docetaxel plus placebo in patients with metastatic CRPC. The study found no significant improvement in overall survival with the addition of zibotentan compared to docetaxel plus placebo[2][6]. 2. **Dasatinib Trial**: A double-blind, randomized, placebo-controlled phase III study evaluating docetaxel plus dasatinib versus docetaxel plus placebo in chemotherapy-naive men with metastatic CRPC. The addition of dasatinib did not improve overall survival[4]. 3. **Capivasertib Trial**: An ongoing phase III double-blind, randomized, placebo-controlled study assessing the efficacy and safety of capivasertib plus docetaxel versus placebo plus docetaxel in patients with metastatic CRPC[3][7]. 4. **ASCENT-1 Study**: A multicenter, double-blind, placebo-controlled trial that suggested DN-101 might enhance the antitumor activity of docetaxel compared to docetaxel plus placebo[5]. ## Efficacy and Safety In the control arms of these trials, docetaxel plus placebo has demonstrated consistent efficacy: - Median overall survival of approximately 19-21 months in patients with metastatic CRPC[2][4] - Median time to pain progression of about 10 months[2] Common adverse events reported in the docetaxel plus placebo arms include: - Gastrointestinal issues (reported in 75% of patients)[5] - Blood and lymphatic disorders (48%)[5] - Fatigue (6% grade 3-4)[4] - Asthenia (3% grade 3-4)[4] - Pleural effusions (<1% grade 3-4)[4] Dose modifications due to docetaxel toxicity were required in approximately 15% of patients receiving docetaxel plus placebo[5].

Other names

docetaxel plus placebo