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 Clinical Study in Three-arm of Lurbinectedin (PM01183) Alone or in Combination With Gemcitabine and a Control Arm With Docetaxel as Second Line Treatment in Non-Small Cell Lung Cancer (NSCLC) Patients

Phase 2
Completed
Conditions
Non-Small Cell Lung Cancer (NSCLC)
Interventions
First Posted Date
2013-09-26
Last Posted Date
2019-09-24
Lead Sponsor
PharmaMar
Target Recruit Count
69
Registration Number
NCT01951157

A Study of the Safety of Subcutaneously Administered Trastuzumab (Herceptin) in Participants With Early and Locally Advanced Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

Phase 3
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2013-09-12
Last Posted Date
2020-11-03
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
240
Registration Number
NCT01940497
Locations
🇮🇹

Ospedale S.G.Calibita Fatebenefratelli; Unità Operativa Oncologia, Roma, Lazio, Italy

🇮🇹

Campus Universitario S.Venuta; Centro Oncologico T.Campanella, Catanzaro, Calabria, Italy

🇮🇹

Ospedale San Carlo; Day Hospital Oncologia Medica, Potenza, Basilicata, Italy

and more 51 locations

Nimotuzumab Plus Docetaxel and Capecitabine Versus Docetaxel and Capecitabine in the Treatment of Breast Cancer Patients

Phase 2
Conditions
Breast Cancer
Interventions
First Posted Date
2013-09-11
Last Posted Date
2015-06-04
Lead Sponsor
Chinese Academy of Medical Sciences
Target Recruit Count
90
Registration Number
NCT01939054
Locations
🇨🇳

Xijing Hospital, Xi-an, Shanxi, China

🇨🇳

The General Hospital of the People's Liberation Army (PLAGH), Beijing, Beijing, China

🇨🇳

Beijing cancer hospital, Beijing, Beijing, China

and more 6 locations

Safety and Tolerability of Trametinib in Combination With Docetaxel in Japanese Subjects With Non-small Cell Lung Cancer

Phase 1
Withdrawn
Conditions
Lung Cancer, Non-Small Cell
Interventions
First Posted Date
2013-09-10
Last Posted Date
2014-07-28
Lead Sponsor
GlaxoSmithKline
Registration Number
NCT01938456

Azacitidine and Entinostat Before Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer

Phase 2
Terminated
Conditions
Recurrent Non-Small Cell Lung Carcinoma
Stage IV Non-Small Cell Lung Cancer
Stage IIIA Non-Small Cell Lung Cancer
Stage IIIB Non-Small Cell Lung Cancer
Interventions
First Posted Date
2013-09-05
Last Posted Date
2018-07-27
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
17
Registration Number
NCT01935947
Locations
🇺🇸

USC Norris Oncology/Hematology-Newport Beach, Newport Beach, California, United States

🇺🇸

Medical University of South Carolina, Charleston, South Carolina, United States

🇺🇸

Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States

and more 2 locations

Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC

Phase 3
Active, not recruiting
Conditions
Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV
Interventions
Drug: Selumetinib
Drug: Placebo
Drug: Docetaxel
Drug: Pegylated G-CSF
First Posted Date
2013-09-02
Last Posted Date
2024-11-25
Lead Sponsor
AstraZeneca
Target Recruit Count
510
Registration Number
NCT01933932
Locations
🇬🇧

Research Site, Wolverhampton, United Kingdom

Radiation Therapy and Docetaxel in Treating Patients With HPV-Related Oropharyngeal Cancer

Phase 2
Completed
Conditions
Human Papillomavirus Infection
Stage I Oropharyngeal Squamous Cell Carcinoma
Stage II Oropharyngeal Squamous Cell Carcinoma
Stage III Oropharyngeal Squamous Cell Carcinoma
Stage IVA Oropharyngeal Squamous Cell Carcinoma
Stage IVB Oropharyngeal Squamous Cell Carcinoma
Interventions
Drug: Docetaxel
Radiation: Hyperfractionation
Radiation: Intensity-Modulated Radiation Therapy
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
First Posted Date
2013-08-30
Last Posted Date
2023-09-21
Lead Sponsor
Mayo Clinic
Target Recruit Count
81
Registration Number
NCT01932697
Locations
🇺🇸

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

NeoMET Study in Neoadjuvant Treatment of Breast Cancer

Phase 2
Terminated
Conditions
pCR Rate
BCT Rate
Safety
Interventions
First Posted Date
2013-08-28
Last Posted Date
2022-04-06
Lead Sponsor
Shanghai Jiao Tong University School of Medicine
Target Recruit Count
92
Registration Number
NCT01929811
Locations
🇨🇳

Linyi People's Hospital, Linyi, Shandong, China

🇨🇳

Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, China

Study of Chemotherapy With Cisplatin/Carboplatin, and Docetaxel With or Without Erlotinib in Patients With Head and Neck Squamous Cell Carcinomas Amenable for Surgical Resection

Phase 2
Completed
Conditions
Head and Neck Cancer
Interventions
Drug: Docetaxel
Other: Placebo
Drug: Erlotinib
Behavioral: Questionnaires
Behavioral: Phone Call
Drug: Chemotherapy
First Posted Date
2013-08-23
Last Posted Date
2025-01-10
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
55
Registration Number
NCT01927744
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

A Study Of PF-05212384 In Combination With Other Anti-Tumor Agents and in Combination With Cisplatin in Patients With Triple Negative Breast Cancer in an Expansion Arm (TNBC)

Phase 1
Completed
Conditions
Neoplasm
Interventions
First Posted Date
2013-08-09
Last Posted Date
2022-09-13
Lead Sponsor
Pfizer
Target Recruit Count
110
Registration Number
NCT01920061
Locations
🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Medical University of South Carolina/ University Hospital, Charleston, South Carolina, United States

🇺🇸

MUSC Health East Cooper, Mount Pleasant, South Carolina, United States

and more 24 locations
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