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
-

Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer

Phase 3
Active, not recruiting
Conditions
Progesterone Receptor Positive
Recurrent Breast Carcinoma
Stage IIA Breast Cancer AJCC v6 and v7
Stage IIB Breast Cancer AJCC v6 and v7
Stage IIIA Breast Cancer AJCC v7
Stage IIIC Breast Cancer AJCC v7
HER2/Neu Positive
Stage IB Breast Cancer AJCC v7
Stage IA Breast Cancer AJCC v7
Interventions
First Posted Date
2011-01-12
Last Posted Date
2024-11-13
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
3270
Registration Number
NCT01275677
Locations
🇺🇸

GenesisCare USA - Henderson, Henderson, Nevada, United States

🇺🇸

Cancer and Blood Specialists-Shadow, Las Vegas, Nevada, United States

🇺🇸

GenesisCare USA - Las Vegas, Las Vegas, Nevada, United States

and more 1270 locations

Concurrent Chemoradiotherapy Using Intensity Modulated Radiotherapy (IMRT) & Docetaxel-cisplatin (or Carboplatin) Followed by Adjuvant Chemotherapy for Inoperable Stage III Non-small-cell Lung Cancer

Phase 2
Completed
Conditions
Lung Neoplasms
Interventions
Drug: DOCETAXEL
Radiation: Intensity Modulated Radiotherapy (IMRT)
Drug: CISPLATIN
First Posted Date
2010-12-24
Last Posted Date
2014-07-16
Lead Sponsor
Sanofi
Target Recruit Count
34
Registration Number
NCT01266512
Locations
🇭🇰

Sanofi-Aventis Administrative Office, Hong Kong, Hong Kong

A Study of Ramucirumab (IMC-1121B) in Participants With Breast Cancer

Phase 1
Completed
Conditions
Breast Cancer
Metastatic Breast Cancer
Interventions
Biological: Ramucirumab
Drug: Docetaxel
First Posted Date
2010-12-08
Last Posted Date
2014-06-18
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
7
Registration Number
NCT01256567
Locations
🇯🇵

ImClone Investigational Site, Osaka, Japan

🇯🇵

Imclone Investigational Site, Nagoya, Japan

Phenelzine Sulfate and Docetaxel in Treating Patients With Prostate Cancer With Progressive Disease After First-Line Therapy With Docetaxel

Phase 2
Terminated
Conditions
Hormone-Resistant Prostate Cancer
Metastatic Prostatic Adenocarcinoma
Prostate Adenocarcinoma
Recurrent Prostate Carcinoma
Interventions
Procedure: Biopsy of Prostate
Drug: Docetaxel
Other: Laboratory Biomarker Analysis
Drug: Phenelzine Sulfate
First Posted Date
2010-12-03
Last Posted Date
2019-10-02
Lead Sponsor
OHSU Knight Cancer Institute
Target Recruit Count
11
Registration Number
NCT01253642
Locations
🇺🇸

Seattle Cancer Care Alliance, Seattle, Washington, United States

🇺🇸

OHSU Knight Cancer Institute, Portland, Oregon, United States

🇺🇸

Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

A Phase I Dose Escalation Trial of Afatinib Plus Gemcitabine or Plus Docetaxel

Completed
Conditions
Neoplasms
Interventions
First Posted Date
2010-12-02
Last Posted Date
2016-05-30
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
94
Registration Number
NCT01251653
Locations
🇫🇷

1200.93.33002 Boehringer Ingelheim Investigational Site, Dijon, France

🇫🇷

1200.93.33001 Boehringer Ingelheim Investigational Site, Saint-Herblain cedex, France

🇫🇷

1200.93.33003 Boehringer Ingelheim Investigational Site, Toulouse, France

Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer

Phase 2
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2010-12-01
Last Posted Date
2014-02-04
Lead Sponsor
Beth Israel Deaconess Medical Center
Target Recruit Count
28
Registration Number
NCT01250717
Locations
🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Safety Study for Intravenous (IV) AC480 (AC480IV) to Treat Advanced Solid Tumors

Phase 1
Withdrawn
Conditions
Solid Tumors
Interventions
Drug: AC480IV
Drug: Docetaxel
First Posted Date
2010-11-22
Last Posted Date
2015-11-01
Lead Sponsor
Daiichi Sankyo
Registration Number
NCT01245543
Locations
🇺🇸

University of California San Francisco (UCSF), San Francisco, California, United States

🇺🇸

South Texas Accelerated Research Therapeutics (START), San Antonio, Texas, United States

Safety and Tolerability Study of ISIS EIF4E Rx in Combination With Docetaxel and Prednisone (CRPC)

Phase 1
Completed
Conditions
Castrate-Resistant Prostate Cancer
Interventions
First Posted Date
2010-11-04
Last Posted Date
2023-10-06
Lead Sponsor
Ionis Pharmaceuticals, Inc.
Target Recruit Count
113
Registration Number
NCT01234025
Locations
🇺🇸

Fort Range Cancer Center, Fort Collins, Colorado, United States

🇺🇸

St. Luke's - Roosevelt Hospital Center, New York, New York, United States

🇵🇱

Clinical Oncology Department and Day Hospitalization Unit, Independent Public Healthcare Facility T. Koszarowski Opolskie Oncology Centre in Opole, Opole, Poland

and more 35 locations

Prostate Cancer, Androgen Deprivation Withdrawal and Intermittent Chemotherapy

Phase 3
Conditions
Advanced Prostate Cancer
Interventions
First Posted Date
2010-10-20
Last Posted Date
2010-10-20
Lead Sponsor
University of Turin, Italy
Target Recruit Count
600
Registration Number
NCT01224405
Locations
🇮🇹

Davide Perroni, Saluzzo, Cuneo, Italy

🇮🇹

Carlo Alberto Raucci, Torino, Italy

🇮🇹

Oscar Alabiso, Novara, Italy

and more 29 locations

Study for Therapy of Locally Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) With Cisplatin / Docetaxel or Oxaliplatin / Docetaxel

Phase 2
Completed
Conditions
Non Small Cell Lung Cancer
Interventions
First Posted Date
2010-10-18
Last Posted Date
2011-11-29
Lead Sponsor
Krankenhaus Nordwest
Target Recruit Count
88
Registration Number
NCT01222312
Locations
🇩🇪

Krankenhaus Nordwest, Frankfurt/Main, Germany

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