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Pharmacologic class: Mitosis inhibitor

Therapeutic class: Antineoplastic

Pregnancy risk category D

FDA Box Warning

• Give under supervision of physician experienced in cancer chemotherapy, in facility with adequate diagnostic and treatment resources.

• Treatment-related death is more likely if patient has abnormal hepatic function, is receiving higher doses, or has non-small-cell lung cancer and history of platinum-based chemotherapy and is receiving drug as a single agent at dosage of 100 mg/m2.

• Generally, drug shouldn't be given to patients with bilirubin level above upper limit of normal (ULN) or those with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) above 1.5 × ULN concomitant with alkaline phosphatase (ALP) level above 2.5 × ULN. Bilirubin elevations or transaminase abnormalities concurrent with ALP abnormalities increases patient's risk for grade 4 neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death. Patients with isolated transaminase elevations above 1.5 × ULN have higher rate of grade 4 febrile neutropenia, but without increased incidence of toxic death. Before each cycle, obtain bilirubin, ALT or AST, and ALP values and have physician review them.

• Don't give to patients with neutrophil count below 1,500 cells/mm3. Obtain frequent blood cell counts to monitor for neutropenia (which may be severe and cause infection).

• Severe hypersensitivity reactions and fatal anaphylaxis (rare) have occurred in patients who received recommended 3-day dexamethasone premedication. If hypersensitivity reaction occurs, discontinue docetaxel immediately and give appropriate therapy. Don't give drug to patients with history of severe hypersensitivity reactions to it or other drugs containing polysorbate 80. Severe fluid retention may occur despite dexamethasone premedication regimen.


Inhibits cellular mitosis by disrupting microtubular network


Injection concentrate: 20 mg, 80 mg

Indications and dosages

Locally advanced or metastatic breast cancer unresponsive to previous regimens

Adults: 60 to 100 mg/m2 I.V. over 1 hour q 3 weeks as single agent

Adjuvant treatment of operable node-positive breast cancer

Adults: 75 mg/m2 1 hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 q 3 weeks for six courses

Locally advanced or metastatic non-small-cell lung cancer (NSCLC) after platinum therapy failure

Adults: 75 mg/m2 I.V. over 1 hour q 3 weeks as single agent

Unresectable locally advanced or metastatic NSCLC in chemotherapynaïve patients

Adults: 75 mg/m2 I.V. over 1 hour q 3 weeks followed by cisplatin as ordered

Androgen-independent (hormone refractory) metastatic prostate cancer

Adults: 75 mg/m2 I.V. over 1 hour q 3 weeks with 5 mg prednisone P.O. b.i.d. continuously

Gastric adenocarcinoma cancer

Adults: 75 mg/m2 as a 1-hour infusion, followed by cisplatin as a 1- to 3-hour infusion (both on day 1 only), followed by fluorouracil given as a 24-hour continuous I.V. infusion for 5 days, starting at the end of the cisplatin infusion. Treatment is repeated q 3 weeks.

Squamous cell carcinoma of head and neck

Adults:Induction chemotherapy followed by radiotherapy-75 mg/m2 I.V. as 1-hour infusion followed by cisplatin 75 mg/m2 I.V. over 1 hour (both on day 1 only), followed by fluorouracil 750 mg/m2 given as 24-hour continuous I.V. infusion daily for 5 days, starting at end of cisplatin infusion. Treatment is repeated q 3 weeks for four cycles.

Adults:Induction chemotherapy followed by chemoradiotherapy-75 mg/m2 I.V. as 1-hour infusion on day 1, followed by cisplatin 100 mg/m2 I.V. as 30-minute to 3-hour infusion, followed by fluorouracil 1,000 mg/m2/day I.V. as continuous infusion from day 1 to day 4. Treatment is repeated q 3 weeks for three cycles.

Dosage adjustment

• Febrile neutropenia


• Hypersensitivity to drug or polysorbate 80
• Hepatic impairment
• Neutrophil count below 1,500 cells/mm3


Use cautiously in:
• females of childbearing age
• pregnant or breastfeeding patients.


• Assess bilirubin, ALT, AST, and ALP levels before starting each cycle of drug therapy.
• Premedicate patient with oral corticosteroids before docetaxel administration to reduce fluid retention and severity of hypersensitivity reactions.
• Premedicate patient with antiemetics and hydrate with I.V. fluids, as prescribed, before cisplatin administration.

Don't let drug concentrate contact plasticized polyvinyl chloride equipment or devices.
• Know that when used for prostate cancer, drug must be given with prednisone, as prescribed.
• Dilute with accompanying diluent solution; rotate vial gently to mix. Once foam has largely dissipated, withdraw prescribed amount of drug and mix in glass or polypropylene bottle or in plastic bag with 250 ml of normal saline solution or dextrose 5% in water.
• Mix solution thoroughly and infuse over 1 hour, using polyethylene-lined infusion set.

Adverse reactions

CNS: fatigue, asthenia, neurosensory deficits, peripheral neuropathy

CV: peripheral edema, cardiac tamponade, pericardial effusion

GI: nausea, vomiting, diarrhea, stomatitis, ascites

Hematologic: anemia, thrombocytopenia, leukopenia

Musculoskeletal: myalgia, joint pain

Respiratory: bronchospasm, pulmonary edema

Skin: alopecia, rash, dermatitis, desquamation, erythema, nail disorders

Other: edema, hypersensitivity reactions including anaphylaxis


Drug-drug.Antineoplastics: additive bone marrow depression

Cyclosporine, erythromycin, ketoconazole, troleandomycin: significant change in docetaxel effects

Live-virus vaccines: increased risk of infection

Patient monitoring

Watch for signs and symptoms of anaphylaxis or other hypersensitivity reactions, especially with first two doses.
• Monitor vital signs and fluid intake and output. Watch for signs and symptoms of fluid overload and bronchospasm.
• Monitor CBC, and assess for signs and symptoms of blood dyscrasias.
• Closely monitor neutrophil and platelet counts before and during therapy.
• Observe I.V. site frequently for extravasation.
• Assess neurologic status to detect neurosensory deficits and peripheral neuropathy.

Patient teaching

• Instruct patient to weigh himself daily and to immediately report sudden weight gain or difficulty breathing.

Tell patient to report signs and symptoms of blood dyscrasias. Inform him that he'll undergo frequent blood testing to monitor these effects.

Advise patient to immediately report rash or difficulty breathing.
• Inform patient that nail disorders and hair loss are common with docetaxel use, but that hair and nails will grow back after therapy ends.
• Advise female patient of childbearing age to use effective contraception during therapy and to notify prescriber if she suspects pregnancy.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs mentioned above.


/do·ce·tax·el/ (do″sĕ-tak´s'l) an antineoplastic agent used particularly in treating carcinoma of the breast and non.


A semisynthetic anticancer drug first derived from the needles of the European yew tree, used in the treatment of breast and non-small cell lung cancer that has not responded to prior therapy and in the treatment of certain other cancers.


An anticancer drug related to the natural substance taxol. A brand name is Taxotere.
References in periodicals archive ?
Based on these promising studies, there are three aspects that we wish to develop as proof of concept for the use of chromatin regulators as novel predictive biomarkers for docetaxel treatment.
In study 3, which evaluated CYRAMZA plus docetaxel in metastatic non-small cell lung cancer (NSCLC), the incidence of severe bleeding was 2.
About Docetaxel Injection Docetaxel is a cytotoxic anticancer agent indicated for treating breast cancer, non-small cell lung cancer, hormone refractory prostate cancer, gastric adenocarcinoma, and squamous cell carcinoma of the head and neck cancer
The most compelling finding from this analysis was that there was a highly significant OS and failure-free survival (FFS) advantage to adding docetaxel to the HT standard of care for locally advanced, non-metastatic prostate cancer.
Docetaxel is used for the treatment of breast cancer, non-small cell lung cancer, prostate cancer that doesn't respond to hormone therapy, head cancer, neck cancer and melanoma.
A similar enhancement of docetaxel was seen with Apoptone in a prostate cancer model, supporting the concept that an apoptosis-inducting drug may increase chemotherapy effects.
Patients in the combination arm had a 21 percent reduction in disease progression, compared to those who received docetaxel alone (hazard ratio, .
2] of docetaxel (Taxotere) intravenously for 1 hour on days 1 and 8, combined with carboplatin (AUC=6) IV on day 1, and repeated every 3 weeks for six cycles.
When stratified and adjusted for the three pre-specified prognostic factors which showed statistically significant imbalances between the two treatment arms (lactate dehydrogenase, hemoglobin and alkaline phosphatase), there was a positive trend toward better overall survival for the patients treated with satraplatin observed in the following three groups: 1) in those patients who had progressed after receiving docetaxel - hazard ratio 0.
Docetaxel, cisplatin, and fluorouracil; docetaxel and cisplatin; and epirubicin, cisplatin, and fluorouracil as systemic treatment for advanced gastric carcinoma: a randomized phase II trial of the Swiss Group for Clinical Cancer Research
In preclinical studies, OGX-427 has shown to significantly reduce levels of Hsp27, induce apoptosis in several cancer cell lines, has single agent anti-tumour activity, and acts as a chemosensitizer with several cytotoxic drugs, including docetaxel.
The study found that after two years, a third of women on docetaxel were still alive compared to one in five women on paclitaxel.