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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TroVax® In Subjects With Hormone Refractory Prostate Cancer (HRPC)

Phase 2
Terminated
Conditions
Hormone Refractory Prostate Cancer
Interventions
Drug: Docetaxel
Drug: TroVax
First Posted Date
2010-09-03
Last Posted Date
2020-10-19
Lead Sponsor
Oxford BioMedica
Target Recruit Count
25
Registration Number
NCT01194960
Locations
🇺🇸

San Bernardino Urology, San Bernardino, California, United States

🇺🇸

Stanford University Medical Center, Stanford, California, United States

🇺🇸

New York University Cancer Institute, New York, New York, United States

and more 4 locations

Study of Endostatin Combined With Docetaxel in the Treatment of Advanced Non-small Cell Lung Cancer Patients

Phase 2
Conditions
Carcinoma, Non-Small-Cell Lung
First Posted Date
2010-09-01
Last Posted Date
2010-09-16
Lead Sponsor
Fudan University
Target Recruit Count
30
Registration Number
NCT01192230
Locations
🇨🇳

Cancer hospital Fudan University, Shanghai, Shanghai, China

Safety and Tolerability Study of GSK1120212, a MEK Inhibitor, in Combination With Docetaxel, Erlotinib, Pemetrexed, Pemetrexed + Carboplatin, Pemetrexed + Cisplatin, or Nab-Paclitaxel

First Posted Date
2010-08-31
Last Posted Date
2017-11-13
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
169
Registration Number
NCT01192165
Locations
🇰🇷

GSK Investigational Site, Seoul, Korea, Republic of

1-Methyl-D-Tryptophan and Docetaxel in Treating Patients With Metastatic Solid Tumors

Phase 1
Completed
Conditions
Unspecified Adult Solid Tumor, Protocol Specific
Interventions
Drug: 1-methyl-d-tryptophan
Drug: docetaxel
Other: diagnostic laboratory biomarker analysis
Other: pharmacological study
First Posted Date
2010-08-30
Last Posted Date
2014-07-24
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
27
Registration Number
NCT01191216
Locations
🇺🇸

Emory University/Winship Cancer Institute, Atlanta, Georgia, United States

🇺🇸

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

🇺🇸

Billings Clinic, Billings, Montana, United States

and more 2 locations

Comparison of Docetaxel/Prednisone to Docetaxel/Prednisone in Combination With OGX-011 in Men With Prostate Cancer

Phase 3
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2010-08-25
Last Posted Date
2016-10-14
Lead Sponsor
Achieve Life Sciences
Target Recruit Count
1022
Registration Number
NCT01188187
Locations
🇳🇱

Teva Investigational Site 852, Rotterdam, Netherlands

🇺🇸

Teva Investigational Site 093, Marina del Rey, California, United States

🇺🇸

Teva Investigational Site 100, Birmingham, Alabama, United States

and more 137 locations

A Study of Chemotherapy and Ramucirumab Versus Chemotherapy Alone in Second Line Non-Small Cell Lung Cancer (NSCLC) Participants Who Received Prior First Line Platinum-based Chemotherapy

Phase 3
Completed
Conditions
Non-Small Cell Lung Cancer
Interventions
Biological: Ramucirumab
Drug: Placebo (for Ramucirumab)
Drug: Docetaxel
First Posted Date
2010-07-23
Last Posted Date
2019-09-25
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
1253
Registration Number
NCT01168973
Locations
🇬🇧

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Wolverhampton, West Midlands, United Kingdom

Biomarkers of Response to Taxotere in HRPC. ICORG 08-08, V2

Completed
Conditions
Metastatic Cancer
Prostate Cancer
First Posted Date
2010-07-12
Last Posted Date
2020-11-17
Lead Sponsor
Cancer Trials Ireland
Target Recruit Count
73
Registration Number
NCT01160705
Locations
🇮🇪

Beaumont Hospital, Dublin, Ireland

🇮🇪

Mater Private Hospital, Dublin, Ireland

🇮🇪

Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital, Dublin, Ireland

and more 2 locations

Phase I Sodium Selenite in Combination With Docetaxel in Castration-resistant Prostate Cancer

Phase 1
Terminated
Conditions
Prostate Cancer Metastatic Disease
Prostate Cancer
Urologic Neoplasms
Interventions
First Posted Date
2010-07-02
Last Posted Date
2017-03-15
Lead Sponsor
Sandy Srinivas
Target Recruit Count
2
Registration Number
NCT01155791
Locations
🇺🇸

Stanford University School of Medicine, Stanford, California, United States

Paclitaxel, Carboplatin and Cetuximab (PCC) With Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) in Previously Untreated Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma

Phase 2
Active, not recruiting
Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
First Posted Date
2010-07-01
Last Posted Date
2024-12-13
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
128
Registration Number
NCT01154920
Locations
🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

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

Docetaxel and Prednisone With or Without Vaccine Therapy in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer

Phase 2
Terminated
Conditions
Hormone-Resistant Prostate Cancer
Prostate Adenocarcinoma
Recurrent Prostate Carcinoma
Stage IV Prostate Cancer
Interventions
Drug: Docetaxel
Other: Laboratory Biomarker Analysis
Drug: Prednisone
Biological: Recombinant Fowlpox-PSA(L155)/TRICOM Vaccine
Biological: Rilimogene Galvacirepvec
First Posted Date
2010-06-16
Last Posted Date
2017-09-19
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
10
Registration Number
NCT01145508
Locations
🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

🇺🇸

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

🇺🇸

Mayo Clinic in Florida, Jacksonville, Florida, United States

and more 11 locations
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