Overview
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.
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
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
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2008/06/26 | Phase 3 | Terminated | |||
2008/06/25 | Phase 1 | Terminated | |||
2008/06/23 | Phase 1 | Completed | |||
2008/06/23 | Phase 3 | Completed | |||
2008/06/23 | Phase 1 | Completed | |||
2008/06/13 | Phase 2 | Completed | |||
2008/06/12 | Phase 2 | Completed | |||
2008/06/04 | Phase 2 | UNKNOWN | University of Ulm | ||
2008/06/03 | Phase 3 | Completed | |||
2008/05/30 | Phase 2 | Completed |
FDA Drug Approvals
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EMA Drug Approvals
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HSA Drug Approvals
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NMPA Drug Approvals
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PPB Drug Approvals
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TGA Drug Approvals
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