MedPath

Docetaxel

Generic Name
Docetaxel
Brand Names
Taxotere, Docetaxel Accord, Docetaxel Kabi
Drug Type
Small Molecule
Chemical Formula
C43H53NO14
CAS Number
114977-28-5
Unique Ingredient Identifier
699121PHCA
Background

Docetaxel is a clinically well established anti-mitotic chemotherapy medication used for the treatment of different types of cancer, including breast, ovarian, and non-small cell lung cancer. Docetaxel is a complex diterpenoid molecule and a semisynthetic analogue of paclitaxel. Docetaxel reversibly binds to microtubulin with high affinity in a 1:1 stoichiometric ratio, allowing it to prevent cell division and promote to cell death. Compared to paclitaxel, docetaxel is two times more potent as an inhibitor of microtubule depolymerization. Docetaxel binds to microtubules but does not interact with dimeric tubulin.

The use of docetaxel may lead to udesired outcomes such as hepatic impairment, hematologic effects, enterocolitis and neutropenic colitis, hypersensitivity reactions, fluid retention, second primary malignancies, embryo-fetal toxicity, and tumor lysis syndrome. Docetaxel was approved by the FDA in 1996 and is available in solution for injection for intravenous or parenteral administration.

Indication

Docetaxel is indicated as a single agent for the treatment of locally advanced or metastatic breast cancer after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC. It is also indicated as a single agent for locally advanced or metastatic non-small cell lung cancer (NSCLC) after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC. For the treatment of metastatic castration-resistant prostate cancer, docetaxel is indicated with prednisone. Docetaxel is also indicated with cisplatin and fluorouracil for untreated, advanced gastric adenocarcinoma, including the gastroesophageal junction, and with cisplatin and fluorouracil for induction treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN).

Associated Conditions
Esophageal Cancer, Ewing's Sarcoma, Locally Advanced Breast Cancer (LABC), Metastatic Bladder Cancer, Metastatic Breast Cancer, Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC), Node Positive Breast Cancer, Ovarian Cancer Metastatic, Small Cell Lung Cancer (SCLC), Soft Tissue Sarcoma, Advanced untreated gastric adenocarcinoma, Locally advanced Squamous cell carcinoma of head and neck, Locally advanced untreated non small cell lung cancer, Metastatic untreated non small cell lung cancer, Refractory, locally advanced Non small cell lung cancer, Refractory, metastatic Non small cell lung cancer, Refractory, metastatic hormone-refractory Prostate cancer

A Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumours[Substudy 01(NSCLC)]

First Posted Date
2025-01-20
Last Posted Date
2025-05-07
Lead Sponsor
Nanjing Leads Biolabs Co.,Ltd
Target Recruit Count
210
Registration Number
NCT06783647
Locations
🇨🇳

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

🇨🇳

Xiangyang Central Hospital, Xiangyang, Hubei, China

🇨🇳

Mianyang Central Hospital, Mianyang, Sichuan, China

Substudy 01I: A Study of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01I/KEYMAKER-U01I)

Phase 2
Not yet recruiting
Conditions
Lung Neoplasm
Interventions
First Posted Date
2025-01-17
Last Posted Date
2025-05-01
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
144
Registration Number
NCT06780098

Evaluation of JSKN016 in the Treatment of Advanced Non-small Cell Lung Cance: a Phase II Clinical Study

Phase 2
Not yet recruiting
Conditions
Advanced Non-small Cell Lung Cancer
Interventions
First Posted Date
2025-01-15
Last Posted Date
2025-01-15
Lead Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Target Recruit Count
220
Registration Number
NCT06775483

A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer

Phase 3
Recruiting
Conditions
Metastatic Castration-resistant Prostate Cancer
Interventions
First Posted Date
2025-01-08
Last Posted Date
2025-05-11
Lead Sponsor
Celgene
Target Recruit Count
960
Registration Number
NCT06764485
Locations
🇮🇪

Local Institution - 0273, Dublin, Ireland

🇮🇹

Local Institution - 0159, Terni, Italy

🇮🇹

Local Institution - 0156, Arezzo, Italy

and more 235 locations

An Exploratory Study of Tislelizumab in Combination with Chemotherapy in Immuno-experienced Patients with EGFR/ALK/ROS1-negative Advanced NSCLC in the Second-line Setting

Phase 2
Recruiting
Conditions
Lung Cancer
Interventions
First Posted Date
2024-12-27
Last Posted Date
2024-12-27
Lead Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Target Recruit Count
22
Registration Number
NCT06749886
Locations
🇨🇳

Shanghai Pulmonary Hospital, Shanghai, China

A Phase III Study of KN026 in Combination With HB1801 ± Carboplatin as Neoadjuvant Treatment for Early or Locally Advanced HER2-Positive Breast Cancer

Phase 3
Recruiting
Conditions
Early or Locally Advanced HER2-positive Breast Cancer
Interventions
First Posted Date
2024-12-24
Last Posted Date
2025-04-24
Lead Sponsor
Shanghai JMT-Bio Inc.
Target Recruit Count
520
Registration Number
NCT06747338
Locations
🇨🇳

Clinical Trials Information Group, Shanghai, China

ResQ201A: Clinical Trial Of N-803 Plus TISLELIZUMAB And DOCETAXEL Versus DOCETAXEL Monotherapy In Participants With Advanced Or Metastatic Non-Small Cell Lung Cancer

Phase 3
Recruiting
Conditions
NSCLC Stage IV
Interventions
First Posted Date
2024-12-20
Last Posted Date
2025-05-06
Lead Sponsor
ImmunityBio, Inc.
Target Recruit Count
460
Registration Number
NCT06745908
Locations
🇺🇸

OPN Healthcare INC, Glendale, California, United States

🇺🇸

OPN Healthcare INC/ Cancer and Blood Specialty Clinic, Los Alamitos, California, United States

A Phase III Study of SHR-A2102 Versus Investigator-selected Therapy in Advanced Urothelial Carcinoma

Phase 3
Recruiting
Conditions
Advanced Urothelial Carcinoma
Interventions
First Posted Date
2024-12-17
Last Posted Date
2025-03-05
Lead Sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
Target Recruit Count
402
Registration Number
NCT06738251
Locations
🇨🇳

Beijing Cancer Hospital, Beijing, Beijing, China

Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer

Phase 2
Recruiting
Conditions
Metastatic Castration Sensitive Prostate Cancer
Interventions
Drug: Luteinizing Hormone-Releasing Hormone (LHRH) analog
Drug: Androgen Receptor Signal Inhibitor (ARSI)
First Posted Date
2024-12-16
Last Posted Date
2025-03-17
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
25
Registration Number
NCT06734130
Locations
🇺🇸

Moffitt Caner Center, Tampa, Florida, United States

Safety, Tolerability, and Preliminary Efficacy of BH011 in Subjects With Non-Muscle-Invasive Bladder Cancer

Phase 1
Recruiting
Conditions
Bladder Cancer
Non Muscle Invasive
Interventions
First Posted Date
2024-12-13
Last Posted Date
2025-01-09
Lead Sponsor
Zhuhai Beihai Biotech Co., Ltd
Target Recruit Count
48
Registration Number
NCT06732531
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