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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Taxotere Prostate Cancer New Indication Registration Trial in China

Phase 3
Completed
Conditions
Prostatic Neoplasms
Interventions
First Posted Date
2007-02-19
Last Posted Date
2012-07-09
Lead Sponsor
Sanofi
Target Recruit Count
228
Registration Number
NCT00436839
Locations
🇨🇳

Sanofi-Aventis Administrative Office, Shanghai, China

Taxotere + Cisplatin in Nasopharyngeal Carcinoma

Phase 2
Completed
Conditions
Nasopharyngeal Neoplasms
Interventions
First Posted Date
2007-02-19
Last Posted Date
2010-11-17
Lead Sponsor
Sanofi
Target Recruit Count
61
Registration Number
NCT00436293
Locations
🇭🇰

Sanofi-Aventis, Hong Kong, Hong Kong

VEGF Trap and Docetaxel in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

Phase 1
Completed
Conditions
Fallopian Tube Cancer
Malignant Tumor of Peritoneum
Recurrent Ovarian Epithelial Cancer
Interventions
Drug: docetaxel
Biological: ziv-aflibercept
Other: laboratory biomarker analysis
Other: pharmacological study
First Posted Date
2007-02-19
Last Posted Date
2019-02-26
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
58
Registration Number
NCT00436501
Locations
🇺🇸

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

🇺🇸

University of Virginia Health System, Charlottesville, Virginia, United States

CETRA: Neoadjuvant Caelyx and Trastuzumab in Her-2 Positive Breast Cancer

Phase 2
Withdrawn
Conditions
Breast Cancer
First Posted Date
2007-02-12
Last Posted Date
2012-07-30
Lead Sponsor
National Cancer Institute, Naples
Registration Number
NCT00434031
Locations
🇮🇹

Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C, Napoli, Italy

Selective Neoadjuvant Treatment According to Immunohistochemical Subtype for HER2 Negative Breast Cancer Patients

First Posted Date
2007-02-07
Last Posted Date
2023-04-03
Lead Sponsor
Spanish Breast Cancer Research Group
Target Recruit Count
189
Registration Number
NCT00432172
Locations
🇪🇸

Onkologikoa, Donostia, Gipuzkoa, Spain

🇪🇸

Hospital Mutua de Terrassa, Terrassa, Barcelona, Spain

🇪🇸

Centro Oncológico Regional de Galicia, A Coruña, Spain

and more 9 locations

Study of Docetaxel/Gemcitabine Followed by Chemo-radiotherapy (Chemo-RT), With or Without Consolidation Chemotherapy, in IIIA/IIIB Non Small Cell Lung Cancer (NSCLC)

Phase 2
Terminated
Conditions
Non Small Cell Lung Cancer
Interventions
First Posted Date
2007-02-06
Last Posted Date
2015-05-29
Lead Sponsor
Hellenic Oncology Research Group
Target Recruit Count
38
Registration Number
NCT00431613
Locations
🇬🇷

University Hospital of Crete, Heraklion, Crete, Greece

🇬🇷

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

and more 7 locations

Perifosine and Docetaxel in Patients With Relapsed Epithelial Ovarian Cancer

Phase 1
Completed
Conditions
Ovarian Cancer
Interventions
First Posted Date
2007-02-05
Last Posted Date
2016-02-19
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
22
Registration Number
NCT00431054
Locations
🇺🇸

UT MD Anderson Cancer Center, Houston, Texas, United States

Randomized Phase III Trial Comparing Sequential Administration of FE75C Followed by Docetaxel Versus Paclitaxel as Adjuvant Chemotherapy in Axillary Lymph Node (+) Breast Cancer

Phase 3
Completed
Conditions
Breast Cancer
Interventions
Drug: Docetaxel
Drug: Paclitaxel
Drug: Epirubicin
Drug: Cyclophosphamide
Drug: 5-fluoruracil
Drug: Granulocyte-colony stimulating growth factor
First Posted Date
2007-02-05
Last Posted Date
2008-01-21
Lead Sponsor
Hellenic Oncology Research Group
Target Recruit Count
478
Registration Number
NCT00431080
Locations
🇬🇷

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

🇬🇷

University General Hospital of Alexandroupolis, Dep of Medical Oncology, Alexandroupolis, Greece

🇬🇷

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

and more 7 locations

Docetaxel and Carboplatin Versus Docetaxel as Second Line Treatment in Patients With Non-Small-Cell Lung Carcinoma (NSCLC)

Phase 3
Completed
Conditions
Non-Small Cell Lung Cancer
Interventions
First Posted Date
2007-02-02
Last Posted Date
2009-01-28
Lead Sponsor
Hellenic Oncology Research Group
Target Recruit Count
135
Registration Number
NCT00430651
Locations
🇬🇷

University Hospital of Crete, Heraklion, Crete, Greece

🇬🇷

"Sotiria" General Hospital, 1st, 3rd, 6th, 7th, 8th Dep of Pulmonary Diseases, Athens, Greece

🇬🇷

"Theagenion" Anticancer Hospital of Thessaloniki, Thessaloniki, Greece

and more 7 locations

Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer

Phase 3
Active, not recruiting
Conditions
Prostate Cancer
Interventions
Drug: docetaxel
Drug: LHRH agonist
Procedure: surgery
First Posted Date
2007-02-01
Last Posted Date
2023-02-09
Lead Sponsor
Alliance for Clinical Trials in Oncology
Target Recruit Count
788
Registration Number
NCT00430183
Locations
🇺🇸

Michiana Hematology-Oncology, PC - Elkhart, Elkhart, Indiana, United States

🇺🇸

Munson Medical Center, Traverse City, Michigan, United States

🇺🇸

Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota, United States

and more 223 locations
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