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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Irinotecan, Radiation Therapy, and Docetaxel With or Without Cisplatin in Treating Patients With Locally Advanced Esophageal Cancer

Phase 1
Completed
Conditions
Esophageal Cancer
Interventions
First Posted Date
2008-01-28
Last Posted Date
2013-03-22
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
27
Registration Number
NCT00601692
Locations
🇺🇸

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

A Phase I, Open-Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6244 (ARRY-142886)

Phase 1
Active, not recruiting
Conditions
Breast Neoplasms
Breast Cancer
Colon Cancer
Colonic Cancer
Kidney Cancer
Colon Neoplasms
Lung Cancer
Melanoma
Interventions
First Posted Date
2008-01-25
Last Posted Date
2024-10-16
Lead Sponsor
AstraZeneca
Target Recruit Count
140
Registration Number
NCT00600496
Locations
🇺🇸

Research Site, Houston, Texas, United States

Assessment of the Efficacy of a Neoadjuvant Combination: "Chemotherapy-targeted Therapy" in Breast Cancer.

Phase 2
Completed
Conditions
Breast Cancer
First Posted Date
2008-01-24
Last Posted Date
2014-03-20
Lead Sponsor
Centre Jean Perrin
Target Recruit Count
35
Registration Number
NCT00600249
Locations
🇫🇷

Hôpital Georges Pianta, Thonon les Bains, France

🇫🇷

Centre Jean Perrin, Clermont-Ferrand, France

🇫🇷

CHU Albert Michallon, Grenoble, France

and more 3 locations

Cetuximab and Radiation Therapy in Laryngeal Cancer Patients Who Have Responded to One Cycle of Chemotherapy (SPORE)

Phase 2
Terminated
Conditions
Cancer of Larynx
Interventions
First Posted Date
2008-01-23
Last Posted Date
2015-12-03
Lead Sponsor
University of Michigan Rogel Cancer Center
Target Recruit Count
4
Registration Number
NCT00599131
Locations
🇺🇸

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

Neoadjuvant Docetaxel on Newly Diagnosed Intermediate and High Grade Cancer of the Prostate

Phase 2
Withdrawn
Conditions
Stage II Prostate Cancer
Adenocarcinoma of the Prostate
Stage I Prostate Cancer
Prostate Cancer
Interventions
First Posted Date
2008-01-23
Last Posted Date
2016-12-08
Lead Sponsor
John P. Fruehauf
Registration Number
NCT00598858

Oxaliplatin and Docetaxel Followed by Cetuximab for Head and Neck Cancer

Phase 2
Terminated
Conditions
Head and Neck Cancer
Carcinoma, Squamous
Interventions
First Posted Date
2008-01-11
Last Posted Date
2017-06-14
Lead Sponsor
University of Kansas Medical Center
Target Recruit Count
16
Registration Number
NCT00591149
Locations
🇺🇸

University of Kansas Medical Center, Kansas City, Kansas, United States

Sorafenib and Docetaxel in Patients With Prostate Cancer That Did Not Respond to Previous Hormone Therapy

Phase 2
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2008-01-09
Last Posted Date
2022-02-17
Lead Sponsor
Abramson Cancer Center at Penn Medicine
Target Recruit Count
18
Registration Number
NCT00589420
Locations
🇺🇸

Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Phase 3
Active, not recruiting
Conditions
Recurrent Laryngeal Squamous Cell Carcinoma
Recurrent Oral Cavity Verrucous Carcinoma
Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7
Recurrent Salivary Gland Carcinoma
Stage IV Major Salivary Gland Cancer AJCC v7
Stage IVA Laryngeal Verrucous Carcinoma AJCC v7
Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
Stage IVC Sinonasal Squamous Cell Carcinoma AJCC v7
Neck Squamous Cell Carcinoma of Unknown Primary
Interventions
First Posted Date
2008-01-09
Last Posted Date
2024-12-27
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
403
Registration Number
NCT00588770
Locations
🇺🇸

Cleveland Clinic-Weston, Weston, Florida, United States

🇺🇸

Emory University Hospital Midtown, Atlanta, Georgia, United States

🇺🇸

Piedmont Hospital, Atlanta, Georgia, United States

and more 778 locations

Docetaxel With Rapid Hormonal Cycling as a Treatment for Patients With Prostate Cancer

Phase 2
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2008-01-07
Last Posted Date
2023-11-07
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
102
Registration Number
NCT00587431
Locations
🇺🇸

Memorial Sloan Kettering Cancer Center, New York, New York, United States

A Study of the Proper Dosage of Lovastatin and Docetaxel for Patients With Cancer

Phase 1
Terminated
Conditions
Any Cancer
Breast Cancer
Interventions
First Posted Date
2008-01-02
Last Posted Date
2018-10-19
Lead Sponsor
Susan L Roeder
Target Recruit Count
9
Registration Number
NCT00584012
Locations
🇺🇸

Holden Comprehensive Cancer Center, Iowa City, Iowa, United States

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