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
-

TAX + Carboplatin or Cisplatin 1st Line Post-Surgery Ovarian

Phase 2
Completed
Conditions
Ovarian Neoplasms
First Posted Date
2007-10-04
Last Posted Date
2007-10-04
Lead Sponsor
Sanofi
Target Recruit Count
47
Registration Number
NCT00539669
Locations
🇰🇷

Sanofi-Aventis, Seoul, Korea, Republic of

TAX + Cisplatin + 5 F/U vs Cisplatin + 5 F/U in SCCHN

Phase 3
Completed
Conditions
Carcinoma, Squamous Cell
First Posted Date
2007-10-04
Last Posted Date
2007-10-04
Lead Sponsor
Sanofi
Target Recruit Count
86
Registration Number
NCT00539630
Locations
🇰🇷

Sanofi-Aventis, Seoul, Korea, Republic of

An Efficacy and Safety Study of Intetumumab (CNTO 95) in Participants With Metastatic Hormone Refractory Prostate Cancer

Phase 2
Completed
Conditions
Prostatic Neoplasms
Interventions
Drug: Docetaxel
Drug: Prednisone
Drug: Placebo
Biological: Intetumumab
First Posted Date
2007-10-01
Last Posted Date
2013-06-20
Lead Sponsor
Centocor, Inc.
Target Recruit Count
131
Registration Number
NCT00537381

Study to Assess Safety/Tolerability/Efficacy of Gefitinib Versus Docetaxel in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Phase 4
Terminated
Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
Drug: Gefitinib
Procedure: CT or MRI
Drug: Docetaxel
First Posted Date
2007-09-27
Last Posted Date
2013-10-01
Lead Sponsor
AstraZeneca
Target Recruit Count
14
Registration Number
NCT00536107
Locations
🇨🇳

Research Site, Taipei, Taiwan

Erlotinib in Combination With Docetaxel in Advanced Hepatocellular and Biliary Tract Carcinomas

Phase 2
Terminated
Conditions
Hepatocellular Carcinoma
Interventions
First Posted Date
2007-09-20
Last Posted Date
2016-02-12
Lead Sponsor
Gabi Chiorean, MD
Target Recruit Count
25
Registration Number
NCT00532441
Locations
🇺🇸

Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States

🇺🇸

Rush-Presbyterian St. Luke's Medical Center, Chicago, Illinois, United States

🇺🇸

Helen F. Graham Cancer Center, Newark, Delaware, United States

and more 9 locations

Triple Negative Breast Cancer Trial

Phase 3
Conditions
Breast Cancer
Interventions
First Posted Date
2007-09-20
Last Posted Date
2019-02-20
Lead Sponsor
Institute of Cancer Research, United Kingdom
Target Recruit Count
400
Registration Number
NCT00532727
Locations
🇬🇧

Guy's and St Thomas' Hospital NHS Foundation Trust, London, United Kingdom

Radiation Therapy, Androgen Suppression, and Docetaxel in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy

Phase 2
Completed
Conditions
Prostate Cancer
Interventions
Drug: bicalutamide
Drug: docetaxel
Drug: flutamide
Drug: LHRH agonist
Radiation: 3-dimensional conformal radiation therapy
Radiation: radiation therapy
First Posted Date
2007-09-12
Last Posted Date
2019-04-24
Lead Sponsor
Radiation Therapy Oncology Group
Target Recruit Count
80
Registration Number
NCT00528866
Locations
🇺🇸

Mary Bird Perkins Cancer Center - Baton Rouge, Baton Rouge, Louisiana, United States

🇺🇸

Mercy Cancer Center at Mercy San Juan Medical Center, Carmichael, California, United States

🇺🇸

Fox Chase Cancer Center CCOP Research Base, Philadelphia, Pennsylvania, United States

and more 67 locations

Taxotere/Temodar/Cisplatin Study in Melanoma Patients

Phase 1
Completed
Conditions
Metastatic Melanoma
Interventions
First Posted Date
2007-09-11
Last Posted Date
2012-07-30
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
23
Registration Number
NCT00527761
Locations
🇺🇸

U.T.M.D. Anderson Cancer Center, Houston, Texas, United States

Docetaxel and Prednisone With or Without Cediranib in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy

Phase 2
Terminated
Conditions
Adenocarcinoma of the Prostate
Stage IV Prostate Cancer
Interventions
Drug: cediranib maleate
Drug: docetaxel
Drug: prednisone
Other: laboratory biomarker analysis
First Posted Date
2007-09-10
Last Posted Date
2018-08-09
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
57
Registration Number
NCT00527124
Locations
🇺🇸

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States

🇺🇸

University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States

🇺🇸

Wayne State University, Detroit, Michigan, United States

and more 1 locations

Docetaxel, 5-Fluorouracil and Oxaliplatin in Adenocarcinoma of the Stomach or Gastroesophageal Junction Patients

Phase 1
Completed
Conditions
Gastrointestinal Diseases
Interventions
First Posted Date
2007-09-06
Last Posted Date
2016-10-31
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
98
Registration Number
NCT00526110
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

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