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

Evaluating the Efficacy and Safety of Pembrolizumab Plus Standard Chemotherapy in the Neoadjuvant Treatment of Local Advanced (LA) HNSCC

Phase 3
Recruiting
Conditions
Head and Neck Squamous Cell Carcinoma
Neoadjuvant Therapy
Pembrolizumab
Interventions
First Posted Date
2023-10-26
Last Posted Date
2023-10-30
Lead Sponsor
Beijing Tongren Hospital
Target Recruit Count
272
Registration Number
NCT06102395
Locations
🇨🇳

Beijing Tongren Hospital, Beijing, Beijing, China

Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma

Phase 2
Recruiting
Conditions
Clinical Stage I Esophageal Adenocarcinoma AJCC v8
Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8
Clinical Stage II Esophageal Adenocarcinoma AJCC v8
Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8
Clinical Stage III Esophageal Adenocarcinoma AJCC v8
Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
Interventions
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Endoscopic Ultrasound
Procedure: Esophagogastroduodenoscopy
Radiation: Hypofractionated Radiation Therapy
Procedure: Positron Emission Tomography
Other: Survey Administration
First Posted Date
2023-10-12
Last Posted Date
2025-04-04
Lead Sponsor
Mayo Clinic
Target Recruit Count
99
Registration Number
NCT06078709
Locations
🇺🇸

Mayo Clinic in Rochester, Rochester, Minnesota, United States

🇺🇸

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

🇺🇸

Mayo Clinic in Florida, Jacksonville, Florida, United States

JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects

First Posted Date
2023-10-12
Last Posted Date
2023-10-12
Lead Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Target Recruit Count
400
Registration Number
NCT06079983
Locations
🇨🇳

Jilin Provincial Cancer Hospital, Changchun, China

🇨🇳

Guangdong Provincial People's Hospital, Guangzhou, China

🇨🇳

Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China

and more 47 locations

Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)

Phase 3
Recruiting
Conditions
Non-small Cell Lung Cancer (NSCLC)
Interventions
First Posted Date
2023-10-10
Last Posted Date
2025-05-16
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
556
Registration Number
NCT06074588
Locations
🇺🇸

UCLA Hematology/Oncology - Santa Monica ( Site 0023), Los Angeles, California, United States

🇺🇸

Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0001), Jacksonville, Florida, United States

🇺🇸

Mid Florida Hematology and Oncology Center ( Site 0005), Orange City, Florida, United States

and more 181 locations

Randomized Phase II Study of ADT + Abiraterone vs ADT + Docetaxel + Abiraterone

Phase 2
Active, not recruiting
Conditions
Prostate Cancer
Interventions
First Posted Date
2023-09-29
Last Posted Date
2024-05-07
Lead Sponsor
Northwestern University
Target Recruit Count
150
Registration Number
NCT06060587
Locations
🇺🇸

Northwestern University, Chicago, Illinois, United States

Phase II Trial of Magrolimab and Cetuximab With Pembrolizumab or Docetaxel for Recurrent/Metastatic Head Neck Squamous Cell Carcinoma

Phase 2
Terminated
Conditions
Head Neck
Squamous Cell Carcinoma of Head and Neck
Interventions
First Posted Date
2023-09-21
Last Posted Date
2024-10-23
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
57
Registration Number
NCT06046482
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Dose-Reduced Docetaxel With Cyclophosphamide for the Treatment of Vulnerable Older Women With Stage I-III HER2 Negative Breast Cancer, the DOROTHY Trial

Phase 2
Recruiting
Conditions
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
HER2-Negative Breast Carcinoma
Interventions
Other: Medical Chart Review
Other: Questionnaire Administration
First Posted Date
2023-09-18
Last Posted Date
2025-01-29
Lead Sponsor
City of Hope Medical Center
Target Recruit Count
174
Registration Number
NCT06042569
Locations
🇺🇸

City of Hope Medical Center, Duarte, California, United States

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Total Neoadjuvant FLOT Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Cancer

Phase 2
Recruiting
Conditions
Gastric Cancer
Stomach Cancer
GastroEsophageal Cancer
Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Advanced Gastric Adenocarcinoma
Gastric Neoplasm
Stomach Neoplasm
Gastrointestinal Cancer
Advanced Gastroesophageal Junction Adenocarcinoma
Interventions
First Posted Date
2023-09-08
Last Posted Date
2025-05-06
Lead Sponsor
Ukrainian Society of Clinical Oncology
Target Recruit Count
150
Registration Number
NCT06028737
Locations
🇺🇦

National Cancer Institute, Kyiv, Ukraine

A Study of BGB-A445 in Combination With Other Investigational Agents in Participants With Non-Small Cell Lung Cancer

Phase 2
Completed
Conditions
Non-Small Cell Lung Cancer
Interventions
First Posted Date
2023-09-08
Last Posted Date
2025-01-10
Lead Sponsor
BeiGene
Target Recruit Count
100
Registration Number
NCT06029127
Locations
🇨🇳

Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, China

🇨🇳

Daping Hospital, Third Military Medical University, Chongqing, Chongqing, China

🇨🇳

Gansu Provincial Hospital, Lanzhou, Gansu, China

and more 15 locations

Neoadjuvant Cadonilimab in Combination With Cisplatin and Nab-paclitaxel in Resectable Head and Neck Squamous Cell Carcinoma

Phase 2
Recruiting
Conditions
Head and Neck Squamous Cell Carcinoma
Locally Advanced Operable
Interventions
First Posted Date
2023-09-05
Last Posted Date
2023-09-05
Lead Sponsor
Xuekui Liu
Target Recruit Count
30
Registration Number
NCT06023875
Locations
🇨🇳

Sun Yat-sen University Cancer Center, 651 Dongfeng East Road, Guangzhou, China

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