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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Dose-dense Biweekly Docetaxel Combined With 5-fluorouracil as First-line Treatment in Advanced Gastric Cancer

Phase 2
Completed
Conditions
Gastric Adenocarcinoma
First Posted Date
2012-03-30
Last Posted Date
2014-11-07
Lead Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Target Recruit Count
39
Registration Number
NCT01567618
Locations
🇨🇳

Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China

A Study of Ramucirumab and Docetaxel in Participants With Solid Tumors

Phase 2
Completed
Conditions
Malignant Solid Tumor
Interventions
Biological: Ramucirumab
Drug: Docetaxel
First Posted Date
2012-03-30
Last Posted Date
2014-10-16
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
22
Registration Number
NCT01567163
Locations
🇺🇸

ImClone Investigational Site, Seattle, Washington, United States

Study of AXL1717 Compared to Docetaxel to Treat Squamous Cell Carcinoma or Adenocarcinoma of the Lung

Phase 2
Completed
Conditions
Non-small-cell Lung Cancer
Squamous Cell Carcinoma
Adenocarcinoma of the Lung
Interventions
Drug: AXL1717
Drug: Docetaxel
First Posted Date
2012-03-23
Last Posted Date
2013-12-05
Lead Sponsor
Axelar AB
Target Recruit Count
100
Registration Number
NCT01561456
Locations
🇧🇾

Gomel Regional Clinical Oncology Center, Gomel, Belarus

🇭🇺

University of Debrecen Medical and Health Science Center, Clinic of Pulmonology, Debrecen, Hungary

🇵🇱

Wladyslaw Bieganski Regional Specialist Hospital, Grudziadz, Poland

and more 21 locations

Sublingual Anvirzel in Advance Non-Small Cell Lung Cancer (NSCLC)

Phase 1
Withdrawn
Conditions
Chemotherapeutic Agent Toxicity
Lung Cancer
Interventions
First Posted Date
2012-03-23
Last Posted Date
2015-06-08
Lead Sponsor
M.D. Anderson Cancer Center
Registration Number
NCT01562301

Docetaxel, Cisplatin, Pegfilgrastim, and Erlotinib Hydrochloride in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Phase 2
Completed
Conditions
Adenocarcinoma of the Lung
Adenosquamous Cell Lung Cancer
Bronchoalveolar Cell Lung Cancer
Large Cell Lung Cancer
Non-small Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer
Squamous Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Interventions
Drug: cisplatin
Biological: pegfilgrastim
Drug: erlotinib hydrochloride
Other: laboratory biomarker analysis
Genetic: polymorphism analysis
Other: pharmacogenomic studies
Genetic: genetic linkage analysis
Drug: docetaxel
First Posted Date
2012-03-20
Last Posted Date
2018-06-29
Lead Sponsor
Wake Forest University Health Sciences
Target Recruit Count
45
Registration Number
NCT01557959
Locations
🇺🇸

Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States

Docetaxel and Cyclophosphamide Compared to Anthracycline-Based Chemotherapy in Treating Women With HER2-Negative Breast Cancer

First Posted Date
2012-03-08
Last Posted Date
2022-04-14
Lead Sponsor
NSABP Foundation Inc
Target Recruit Count
1871
Registration Number
NCT01547741
Locations
🇺🇸

Grant Medical Center, Columbus, Ohio, United States

🇺🇸

Texas Oncology Methodist Charlton Cancer Center, Dallas, Texas, United States

🇺🇸

Cedars-Sinai Medical Center, Los Angeles, California, United States

and more 898 locations

PI3K Inhibitor BKM120 and Docetaxel in Treating Patients With Advanced Solid Tumor That is Locally Advanced, Cannot Be Removed By Surgery, or Metastatic

Phase 1
Completed
Conditions
Unspecified Adult Solid Tumor, Protocol Specific
Interventions
Drug: PI3K inhibitor BKM120
Drug: docetaxel
Other: pharmacological study
Other: questionnaire administration
Other: laboratory biomarker analysis
First Posted Date
2012-02-28
Last Posted Date
2022-07-22
Lead Sponsor
Roswell Park Cancer Institute
Target Recruit Count
38
Registration Number
NCT01540253
Locations
🇺🇸

Roswell Park Cancer Institute, Buffalo, New York, United States

Gemcitabine Hydrochloride and Docetaxel Followed by Doxorubicin Hydrochloride or Observation in Treating Patients With High-Risk Uterine Leiomyosarcoma Previously Removed by Surgery

Phase 3
Terminated
Conditions
Stage I Uterine Sarcoma AJCC v7
Uterine Corpus Leiomyosarcoma
Interventions
Other: Clinical Observation
Drug: Docetaxel
Drug: Doxorubicin Hydrochloride
Biological: Filgrastim
Drug: Gemcitabine Hydrochloride
Biological: Pegfilgrastim
First Posted Date
2012-02-15
Last Posted Date
2020-04-28
Lead Sponsor
Gynecologic Oncology Group
Target Recruit Count
38
Registration Number
NCT01533207
Locations
🇺🇸

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States

🇺🇸

Piedmont Hospital, Atlanta, Georgia, United States

🇺🇸

Grant Medical Center, Columbus, Ohio, United States

and more 618 locations

Biochemical Recurrence Rate of Radical Prostatectomy Combined With Neoadjuvant and Adjuvant Chemotherapy in High Risk Prostate Cancer

Not Applicable
Conditions
Prostate Cancer
Interventions
First Posted Date
2012-02-09
Last Posted Date
2012-02-09
Lead Sponsor
Hanjong Ahn
Target Recruit Count
70
Registration Number
NCT01530295
Locations
🇰🇷

Jungmin Lee, Seoul, Korea, Republic of

Trial of Eribulin/Cyclophosphamide or Docetaxel/Cyclophosphamide as Neoadjuvant Therapy in Locally Advanced HER2-Negative Breast Cancer

Phase 2
Completed
Conditions
HER2 Negative Breast Cancer
Interventions
First Posted Date
2012-02-07
Last Posted Date
2016-11-04
Lead Sponsor
SCRI Development Innovations, LLC
Target Recruit Count
76
Registration Number
NCT01527487
Locations
🇺🇸

Woodlands Medical Specialists, Pensacola, Florida, United States

🇺🇸

Nebraska Methodist Cancer Center, Omaha, Nebraska, United States

🇺🇸

Northeast Georgia Medical Center, Gainesville, Georgia, United States

and more 12 locations
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