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
-

Phase 3 Study of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Late-stage Non-squamous Non-small-cell Lung Cancer

Phase 3
Completed
Conditions
Non-Small-Cell Lung Cancer Metastatic
Non-Small-Cell Lung Carcinoma
Non-Small Cell Lung Cancer
Non-Small-Cell Lung Cancer Stage IIIB
Non-Small-Cell Lung Cancer Stage IV
Carcinoma, Non-Small-Cell Lung
Nonsmall Cell Lung Cancer
Interventions
Biological: bavituximab
Other: Placebo (for bavituximab)
Drug: Docetaxel
First Posted Date
2013-12-03
Last Posted Date
2017-04-21
Lead Sponsor
Peregrine Pharmaceuticals
Target Recruit Count
582
Registration Number
NCT01999673
Locations
🇺🇦

Peregrine Pharmaceuticals Investigational Site, Uzhgorod, Ukraine

Sequential Administration of FE75C and Docetaxel Versus Docetaxel/Cyclophosphamide in HER-2 Negative, Node Positive Breast Cancer

Phase 3
Completed
Conditions
Breast Cancer
Interventions
Drug: Docetaxel
Drug: Epirubicin
Drug: Cyclophosphamide
Drug: 5-fluoruracil
Drug: Granulocyte-colony stimulating growth factor
First Posted Date
2013-11-15
Last Posted Date
2014-05-14
Lead Sponsor
Hellenic Oncology Research Group
Target Recruit Count
650
Registration Number
NCT01985724
Locations
🇬🇷

"IASO" General Hospital of Athens, 1st Dep of Medical Oncology, Athens, Greece

🇬🇷

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine, Athens, Greece

🇬🇷

Air Forces Military Hospital of Athens, Athens, Greece

and more 7 locations

Bevacizumab in Combination With Chemotherapy in the Neo-adjuvant Setting for HER2 (-) Breast Cancer

Phase 2
Terminated
Conditions
Breast Cancer
Interventions
First Posted Date
2013-11-15
Last Posted Date
2015-10-08
Lead Sponsor
Hellenic Oncology Research Group
Target Recruit Count
34
Registration Number
NCT01985841
Locations
🇬🇷

"IASO" General Hospital of Athens, Athens, Greece

🇬🇷

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology, Piraeus, Greece

🇬🇷

University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece, Heraklion, Greece

and more 3 locations

A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer

First Posted Date
2013-10-21
Last Posted Date
2022-06-14
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
1846
Registration Number
NCT01966471
Locations
🇨🇦

Princess Margaret Cancer Center, Toronto, Ontario, Canada

🇦🇺

Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia

🇯🇵

Niigata Cancer Ctr Hospital; Breast Surgery, Niigata, Japan

and more 292 locations

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

Phase 3
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2013-10-17
Last Posted Date
2019-04-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
174
Registration Number
NCT01964391
Locations
🇩🇿

EHS Oncologie Emir Abdelkader Oran; Service d'Oncologie Médicale, Oran, Algeria

🇩🇿

Centre Anti Cancer Beau-fraisier;Service d'oncologie médicale, Algiers, Algeria

🇩🇿

CHU Annaba; Service d'Oncologie Médicale, Annaba, Algeria

and more 20 locations

Trastuzumab and Pertuzumab or Bevacizumab With Combination Chemotherapy in Treating Patients With Stage II-III Breast Cancer

Phase 2
Completed
Conditions
Stage II Breast Cancer
Stage IIIC Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Interventions
First Posted Date
2013-10-10
Last Posted Date
2019-03-05
Lead Sponsor
Case Comprehensive Cancer Center
Target Recruit Count
16
Registration Number
NCT01959490
Locations
🇺🇸

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Gemcitabine Hydrochloride, Docetaxel, and Radiation Therapy in Treating Patients With Uterine Sarcoma That Has Been Removed By Surgery

Not Applicable
Terminated
Conditions
Stage IC Uterine Sarcoma
Stage IB Uterine Sarcoma
Stage IVA Uterine Sarcoma
Stage IA Uterine Sarcoma
Stage IIA Uterine Sarcoma
Stage IIIA Uterine Sarcoma
Stage IVB Uterine Sarcoma
Stage IIIB Uterine Sarcoma
Stage IIB Uterine Sarcoma
Stage IIIC Uterine Sarcoma
Interventions
Drug: Gemcitabine Hydrochloride
Drug: Docetaxel
Radiation: Internal Radiation Therapy
Radiation: Intensity-Modulated Radiation Therapy
Radiation: External Beam Radiation Therapy
Other: Laboratory Biomarker Analysis
First Posted Date
2013-10-09
Last Posted Date
2023-08-16
Lead Sponsor
Albert Einstein College of Medicine
Target Recruit Count
3
Registration Number
NCT01958580
Locations
🇺🇸

Albert Einstein College of Medicine, Bronx, New York, United States

A Study of Vantictumab (OMP-18R5) in Combination With Docetaxel in Patients With Previously Treated NSCLC

Phase 1
Completed
Conditions
Solid Tumors
Interventions
First Posted Date
2013-10-08
Last Posted Date
2020-09-09
Lead Sponsor
OncoMed Pharmaceuticals, Inc.
Target Recruit Count
34
Registration Number
NCT01957007
Locations
🇺🇸

Roswell Park Cancer Center, Elm & Carlton Streets, Buffalo, New York, United States

🇺🇸

Case Western Reserve University, Cleveland, Ohio, United States

🇺🇸

University of Colorado, Aurora, Colorado, United States

A Phase III Study for Patients With Metastatic Hormone-naïve Prostate Cancer

Phase 3
Active, not recruiting
Conditions
Metastatic Prostate Cancer
Interventions
Radiation: radiotherapy
Drug: abiraterone acetate
Other: Androgen Deprivation Therapy
Drug: Docetaxel
First Posted Date
2013-10-08
Last Posted Date
2024-11-11
Lead Sponsor
UNICANCER
Target Recruit Count
1173
Registration Number
NCT01957436
Locations
🇪🇸

Hospital Germans Trias i Pujol, Badalona, Spain

🇪🇸

Vall d'Hebron University Hospital, Barcelona, Spain

🇪🇸

ICO Girona - Hospital Josep Trueta, Girona, Spain

and more 74 locations

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
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