Paclitaxel (Taxol)

==General information==
Class/mechanism: Taxane, promotes assembly of microtubules, stablizes microtubules, preventing depolymerization. Paclitaxel interferes with the normal dynamic reorganization of microtubules that is necessary for regular interphase/mitosis processes. It also leads to creation of abnormal bundles of microtubules. Paclitaxel is highly lipophilic/insoluble in water and needs to be dissolved in Cremophor EL (polyoxyethylated castor oil), which may cause hypersensitivity infusion reactions.Paclitaxel (Taxol) package insert Paclitaxel (Taxol) package insert (locally hosted backup)
Route: IV
Extravasation: irritant (usually), vesicant (rare) 
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, or the prescribing information. 
==Diseases for which it is established (work in progress)==
*Breast cancer
*Kaposi sarcoma
*Non-small cell lung cancer
**Non-small cell lung cancer, nonsquamous
**Non-small cell lung cancer, squamous
*Ovarian cancer
**Low-grade serous ovarian cancer
==Diseases for which it is used==
*Anal cancer
*Angiosarcoma
*Carcinoma of unknown primary
*Cervical cancer
*Cutaneous basal cell carcinoma
*Diffuse large B-cell lymphoma
*Endometrial cancer
*Esophageal cancer
**Esophageal adenocarcinoma
**Esophageal squamous cell carcinoma
*Gastric cancer
*Head and neck cancer
*Melanoma
*Nasopharyngeal carcinoma
*Penile cancer
*Prostate cancer
*Small cell lung cancer
*Testicular cancer
*Thymoma
*Urothelial carcinoma
**Bladder cancer
*Vulvar cancer
==Patient drug information==
*Paclitaxel (Taxol) package insert
*Paclitaxel (Taxol) patient drug information (Chemocare)Paclitaxel (Taxol) patient drug information (Chemocare)
*Paclitaxel (Taxol) patient drug information (UpToDate)Paclitaxel (Taxol) patient drug information (UpToDate)
==History of changes in FDA indication==
===Breast cancer===
* 1998-04-09 (oldest label available at Drugs @ FDA): Indicated for the treatment of breast cancer after failure of combination therapy for metastatic disease. Prior therapy should have included an anthracycline unless clinically contraindicated. (Based on Nabholtz et al. 1996)
* 1998-04-09 (oldest label available at Drugs @ FDA): Indicated for the treatment of breast cancer relapsed within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. (Based on Nabholtz et al. 1996)
* 1999-10-25: New indication for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. (Based on INT 0148/CALGB 9344)
===Ovarian cancer===
* 1992-12-29: Initial FDA approval for treatment of patients with metastatic carcinoma of the ovary after failure of first-line or subsequent chemotherapy. (Based on Eisenhauer et al. 1994)
* 1998-04-09 (oldest label available at Drugs @ FDA): Indicated for first-line therapy in combination with cisplatin for the treatment of advanced carcinoma of the ovary. (Based on GOG 111 & OV10)
* 1998-04-09 (oldest label available at Drugs @ FDA): Indicated for subsequent therapy for the treatment of advanced carcinoma of the ovary. (Based on GOG 111 & OV10)
===Kaposi sarcoma===
* 1998-04-09 (oldest label available at Drugs @ FDA): Indicated for the second-line treatment of AIDS-related Kaposi's sarcoma. (Based on CA139-174 & CA139-281)
===Non-small cell lung cancer===
* 1998-06-30: New indication added: in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. (Based on ECOG E5592)
==History of changes in EMA indication==
*1992-12-29: EURD
==History of changes in PMDA indication==
*2005-05-31: New indication for the treatment of cancer of the uterus body.
*2012-03-21: New additional indications and new dosages for the treatment of relapsed or metastatic head and neck cancer. 
*2012-03-21: New additional indications and new dosages for the treatment of relapsed or metastatic esophagus cancer.
*2012-03-21: New additional indications and new dosages for the treatment of angiosarcoma.
*2012-03-21: New additional indications and new dosages for the treatment of advanced or relapsed cervical cancer.
*2013-02-21: New additional indications and a new dosage for the treatment of relapsed or refractory germ cell tumors (testicular tumors, ovarian tumors, extragonadal tumors).
==Also known as==
*Brand names:
Synonyms 	Synonyms 	Synonyms	Synonyms 	Synonyms 	Synonyms 	Synonyms	Synonyms
Abitaxel 	Altaxel 	Anzatax 	Anzatec 	Apealea 	Asotax 	Betaxel 	Bristaxol
Britaxol 	Clitaxel 	Cytax 	Daburex 	Dalys 	Drifen 	Ebetaxel	Formoxol
Genexol 	Genetaxyl 	Gros 	Ifaxol 	Intaxel 	Magytax 	Medixel 	Mitotax
Neotacs 	Neotaxan 	Neotaxl 	Ofoxel 	Oncotaxel	Onxol 	Paclitax	Paclitaxin
Pacliteva 	Pacxel 	Padexol 	Paklitaxfil	Panataxel	Parexel 	Paxene 	Paxenor
Paxus 	Pazenir 	Petaxel 	Phyxol 	Poltaxel 	Praxel 	Ribotax 	Sindaxel
Taclipaxol	Tarvexol 	Taxocris	Taxodiol 	Taxol 	Taxomedac	Taycovit	Unitaxel
Yewtaxan 	Naveruclif	 	 	 	 	 	
==References==
Category:Drugs
Category:Intracavitary medications
Category:Intravenous medications
Category:Irritant
Category:Vesicant
Category:Taxanes
Category:Microtubule inhibitors
Category:Anal cancer medications
Category:Angiosarcoma medications 
Category:Bladder cancer medications
Category:Breast cancer medications
Category:Carcinoma of unknown primary medications 
Category:Cervical cancer medications
Category:Cutaneous basal cell carcinoma medications
Category:Diffuse large B-cell lymphoma medications
Category:Endometrial cancer medications
Category:Esophageal adenocarcinoma medications
Category:Esophageal cancer medications
Category:Esophageal squamous cell carcinoma medications
Category:Gastric cancer medications
Category:Head and neck cancer medications
Category:Kaposi sarcoma medications
Category:Low-grade serous ovarian cancer medications
Category:Melanoma medications 
Category:Nasopharyngeal carcinoma medications
Category:Non-small cell lung cancer medications
Category:Non-small cell lung cancer, nonsquamous medications
Category:Non-small cell lung cancer, squamous medications
Category:Ovarian cancer medications
Category:Penile cancer medications 
Category:Prostate cancer medications
Category:Small cell lung cancer medications
Category:Testicular cancer medications
Category:Thymoma medications
Category:Urothelial carcinoma medications
Category:Vulvar cancer medications
Category:FDA approved in 1992
Category:EMA approved in 1992
Category:PMDA approved drugs
Category:WHO Essential Cancer Medicine