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
Associated Therapies
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A Study of Bevacizumab Added to Trastuzumab Plus Docetaxel in the Neoadjuvant Setting in Participants With Early Stage HER2-Positive Breast Cancer

Phase 2
Completed
Conditions
Breast Cancer
Interventions
Drug: Bevacizumab
Drug: Docetaxel
Drug: Trastuzumab
Procedure: Surgery
Radiation: Radiotherapy
Drug: Hormonal Therapy
First Posted Date
2010-06-11
Last Posted Date
2018-03-16
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
152
Registration Number
NCT01142778
Locations
🇫🇷

Centre Leon Berard; Oncologie Genetique, Lyon, France

🇫🇷

Centre D'Oncologie de Gentilly; Oncology, Nancy, France

🇫🇷

Centre Radiotherapie Marie Curie, Arras, France

and more 25 locations

A Phase II, Randomized, Open-label Study of Lapatinib Plus Chemotherapy Versus Trastuzumab Plus Chemotherapy in HER2-positive and p95HER2-positive Metastatic Breast Cancer

Phase 2
Withdrawn
Conditions
Neoplasms, Breast
Interventions
First Posted Date
2010-06-07
Last Posted Date
2013-03-13
Lead Sponsor
GlaxoSmithKline
Registration Number
NCT01137994

A Chinese Randomized Crossover Study of Erlotinib Versus Docetaxel/Cisplatin in Previously Untreated Stage IIIB/IV Lung Adenocarcinoma With EGFR Mutations

Phase 2
Conditions
Neoplasms, Lung
Carcinoma, Non-Small Cell Lung
Drug Therapy
Genes, EGFR
Interventions
First Posted Date
2010-05-27
Last Posted Date
2010-05-27
Lead Sponsor
Chinese PLA General Hospital
Target Recruit Count
60
Registration Number
NCT01131429
Locations
🇨🇳

Chinese PLA General Hospital, Beijing, Beijing, China

Pralatrexate and Docetaxel in Treating Patients With Stage IV Esophageal or Gastroesophageal Cancer Who Have Failed Platinum-Based Therapy

Phase 2
Completed
Conditions
Adenocarcinoma of the Esophagus
Adenocarcinomas of the Gastroesophageal Junction
Recurrent Esophageal Cancer
Stage IV Esophageal Cancer
Squamous Cell Carcinoma of the Esophagus
Interventions
Drug: pralatrexate
Drug: docetaxel
Radiation: fludeoxyglucose F 18
Procedure: positron emission tomography
First Posted Date
2010-05-24
Last Posted Date
2016-06-01
Lead Sponsor
Ohio State University Comprehensive Cancer Center
Target Recruit Count
6
Registration Number
NCT01129206
Locations
🇺🇸

Ohio State University, Columbus, Ohio, United States

A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)

Phase 3
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2010-05-10
Last Posted Date
2024-03-04
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
1095
Registration Number
NCT01120184
Locations
🇹🇭

Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology, Bangkok, Thailand

🇹🇷

Gazi Uni Medical Faculty Hospital; Oncology Dept, Ankara, Turkey

🇬🇧

Bristol Haematology and Oncology centre, Bristol, United Kingdom

and more 254 locations

Radiation Therapy and Chemotherapy, With or Without Cetuximab, Followed by Surgery in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed by Surgery

Phase 3
Completed
Conditions
Adenocarcinoma of the Gastroesophageal Junction
Esophageal Cancer
Interventions
Biological: cetuximab
Drug: cisplatin
Drug: docetaxel
Procedure: adjuvant therapy
Procedure: neoadjuvant therapy
First Posted Date
2010-04-21
Last Posted Date
2020-10-20
Lead Sponsor
Swiss Group for Clinical Cancer Research
Target Recruit Count
297
Registration Number
NCT01107639
Locations
🇨🇭

Hôpital du Valais (RSV)-CHCVs, Sion, Switzerland

🇨🇭

Kantonsspital Winterthur, Winterthur, Switzerland

🇨🇭

City Hospital Triemli, Zurich, Switzerland

and more 54 locations

Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Patients With Non-Small Cell Lung Cancer

Phase 2
Completed
Conditions
Non-small Cell Lung Cancer
Interventions
First Posted Date
2010-04-21
Last Posted Date
2019-09-11
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
180
Registration Number
NCT01107444
Locations
🇬🇧

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Manchester, United Kingdom

A Study of Alpharadin With Docetaxel in Patients With Bone Metastasis From Castration-Resistant Prostate Cancer (CRPC)

Phase 1
Completed
Conditions
Castration-Resistant Prostate Cancer
Bone Metastases
Interventions
First Posted Date
2010-04-19
Last Posted Date
2017-01-04
Lead Sponsor
Bayer
Target Recruit Count
70
Registration Number
NCT01106352

Neo-Adjuvant Chemotherapy (TAC) With or Without Zoledronic Acid in Treating HER2-negative Breast Cancer Patients

Phase 3
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2010-04-07
Last Posted Date
2020-01-21
Lead Sponsor
Borstkanker Onderzoek Groep
Target Recruit Count
250
Registration Number
NCT01099436
Locations
🇳🇱

Leiden University Medical Center, Leiden, Netherlands

Dose Escalation, Safety and Pharmacokinetic Study of AVE8062 Combined With Docetaxel and Cisplatin in Patients With Solid Tumors

Phase 1
Completed
Conditions
Neoplasms, Malignant
Interventions
First Posted Date
2010-03-30
Last Posted Date
2013-10-16
Lead Sponsor
Sanofi
Target Recruit Count
11
Registration Number
NCT01095302
Locations
🇯🇵

Investigational Site Number 392001, Koto-Ku, Japan

🇯🇵

Investigational Site Number 392003, Akashi-Shi, Japan

🇯🇵

Investigational Site Number 392002, Nagoya-Shi, Japan

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