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Drug Formulary information is intended for use by healthcare professionals. It is not intended to be medical advice. Some of the information, including information about funding for cancer drugs, does not apply to all patients. Cancer treatment plans are unique to each patient. If you are a patient, please speak with your healthcare team to understand how this information applies to you.

A - Regimen Name

DOCE Regimen
DOCEtaxel


Disease Site
Lung
Non-Small Cell


Intent
Palliative

Regimen Category
Evidence-Informed :

Regimen is considered appropriate as part of the standard care of patients; meaningfully improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR).  Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.


Rationale and Uses

Treatment of locally advanced or metastatic non-small cell lung cancer

 
B - Drug Regimen

DOCEtaxel
75 mg /m² IV Day 1
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C - Cycle Frequency

REPEAT EVERY 21 DAYS

Unless disease progression or unacceptable toxicity occurs

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Low

Other Supportive Care:

Also refer to CCO Antiemetic Summary

 

Pre-medications (prophylaxis for infusion reaction):

  • Dexamethasone* 8 mg PO BID for 3 days, starting 1-day pre-infusion

    * Do not discontinue dexamethasone, even in the absence of an IR, due to the benefits on other adverse effects (e.g. pain and edema).
    Dexamethasone 10-20 mg IV can be given if patient forgot to take oral doses.
 
E - Dose Modifications

Doses should be modified according to the protocol by which the patient is being treated. 

Dosage with toxicity

Toxicity (worst in previous cycle)

Docetaxel dose*

Febrile neutropenia / Grade 4 ANC ≥ 7 d

75% of previous dose

Grade 3 skin/ neuro/ major organ/ non-hematologic toxicity

75% of previous dose
Any occurrence of cystoid macular edema Hold and investigate; refer patient promptly an ophthalmic examination. Discontinue if confirmed.
Grade 4 skin/ neuro/ major organ/ non-hematologic toxicity
OR
Recurrence of Grade 3 toxicity after prior dose reduction
Discontinue

* Do not retreat until ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, and toxicity ≤ grade 2.

 

Management of Infusion-related reactions:

Also refer to the CCO guideline for detailed description of Management of Cancer Medication-Related Infusion Reactions.

 

Grade Management Re-challenge
1 or 2
  • Stop or slow the infusion rate.
  • Manage the symptoms.

Restart:

  • After symptom resolution, restart with pre-medications ± reduced infusion rate.
  • Consider re-challenge with pre-medications and at a reduced infusion rate.
  • After 2 subsequent IRs, replace with a different taxane. Give intensified pre-medications and reduce the infusion rate.
  • May consider adding oral montelukast ± oral acetylsalicylic acid.
3 or 4
  • Stop treatment.
  • Aggressively manage symptoms.
  • Re-challenge is discouraged, especially if vital symptoms have been affected.
  • Consider desensitization if therapy is necessary.
  • There is insufficient evidence to recommend substitution with another taxane at re-challenge.
  • High cross-reactivity rates have been reported.

 



Hepatic Impairment

Patients with hepatic impairment have a higher risk of severe adverse effects, including fatal gastrointestinal hemorrhage, sepsis and myelosuppression.

 

Bilirubin  

AST and/or ALT

 

Alkaline Phosphatase

Docetaxel dose

> ULN AND Any AND Any

Do not treat. Discontinue if treatment already started.

Any AND
> 1.5 X ULN

AND

> 2.5 x ULN


Renal Impairment

No adjustment required.

 


Dosage in the Elderly

No adjustment required, but caution should be exercised in elderly patients with poor performance status who are receiving docetaxel.

 

 


 
F - Adverse Effects

Refer to DOCEtaxel drug monograph(s) for additional details of adverse effects.


Very common (≥ 50%)

Common (25-49%)

Less common (10-24%)

Uncommon (< 10%),

but may be severe or life-threatening

  • Fatigue
  • Myelosuppression +/- bleeding (may be severe)
  • Alopecia (may be permanent)
     
  • Edema (may be severe)
  • Neuropathy (may be severe)
  • Nausea/vomiting
  • Mucositis (may be severe)
  • Diarrhea (may be severe, especially with neutropenia)
  • Rash (may be severe)
  • Nail disorder
  • Hypersensitivity (may be severe)
  • Musculoskeletal pain
  • Arrhythmia
  • Cardiotoxicity
  • Arterial thromboembolism
  • Venous thromboembolism
  • GI obstruction / perforation
  • Radiation and injection site recall reaction
  • ↑ LFTs
  • Seizure
  • Cystoid macular edema
  • Tear duct obstruction
  • Pneumonitis/Adult Respiratory Distress Syndrome (ARDS)
  • Disseminated intravascular coagulation (DIC)
  • Secondary malignancies
  • Hand-foot syndrome
  • Nephrotoxicity
 
G - Interactions

Refer to DOCEtaxel drug monograph(s) for additional details


  • Avoid concomitant use with CYP3A4 inhibitors.  If must use together, consider decreasing docetaxel dose (50% for strong inhibitors).
  • Caution with CYP3A4 inducers and substrates
  • Avoid concurrent use with dronedarone
 
H - Drug Administration and Special Precautions

Refer to DOCEtaxel drug monograph(s) for additional details


Administration:

  • Refer to the respective product monographs for preparation instructions.  Mix in 250mL D5W or NS to a maximum concentration of 0.3-0.74 mg/mL.  For doses over 200mg, use a larger volume of the infusion vehicle so the maximum concentration is not exceeded.
  • Infuse through main IV line over 1 hour.
  • In order to minimize patients' exposure to DEHP leaching from PVC bags or sets, use polyolefin or polypropylene infusion bags and polyethylene-lined administration sets.
  • To minimize hypersensitivity reactions, docetaxel infusion should be started at a slow rate, then increased incrementally to planned rate.
  • Monitor patient for signs of alcohol intoxication (due to alcohol content in formulation) during and after the infusion.
  • Injection site recall reactions (recurrence of skin reaction at a previous extravasation site after docetaxel is administered at a different site) have been observed.
     

Also refer to the CCO guideline for detailed description of Management of Cancer Medication-Related Infusion Reactions.
 

Contraindications:

  • Patients who have a history of severe hypersensitivity reactions to docetaxel, to other drugs formulated with polysorbate 80 or polyethylene glycol 300, or to any components of the formulation
  • Patients with baseline neutrophil counts of <1.5 x 109/L 
  • Patients with severe liver impairment
     

Other Warnings/Precautions:

  • Patients with:
    • bilirubin > ULN or
    • AST and/or ALT > 1.5 x ULN and ALP > 2.5 x ULN or 
    • ANC < 1.5 x 109/L
    • (refer to dose modifications section)
  • Use with caution in patients with pre-existing effusions or ascites.
  • Use with caution in patients who have hypersensitivity to paclitaxel.
  • Docetaxel contains ethanol (± 1g/m2; refer to respective product monographs) and may cause drowsiness. Patients should be cautioned regarding driving and the use of machinery immediately after receiving the infusion. Ethanol may be harmful to patients at risk of adverse effects such as those with alcoholism, liver disease, epilepsy and children. Cases of alcohol intoxication have been reported.
     

Pregnancy/Lactation:

  • Docetaxel is contraindicated in pregnancy and lactation.  Adequate contraception must be used by both sexes, during docetaxel treatment and for at least 6 months after the last dose.  Fertility may be affected.
 
I - Recommended Clinical Monitoring

Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.

Recommended Clinical Monitoring

  • CBC, including nadir counts; baseline and before each dose
  • Liver function tests; baseline and before each dose
  • Clinical toxicity assessment of infection, bleeding, neurotoxicity, fluid retention, hypersensitivity, lethargy, cutaneous reactions, thromboembolism, musculoskeletal pain, cardiovascular, ophthalmic, GI or respiratory effects, enterocolitis with neutropenia; at each visit
  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version


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J - Administrative Information

Approximate Patient Visit
2 hours
Pharmacy Workload (average time per visit)
23.936 minutes
Nursing Workload (average time per visit)
54.167 minutes
 
K - References

Docetaxel drug monograph, Cancer Care Ontario.

Shepherd FA, Dacey J, Ramlan R, et al: Prospective randomized trial of Docetaxel versus best supportive care in patients with non-small cell lung cancer previously treated with platinum-based chemotherapy. J. Clin Onc, 18:2095-2103, 2000

Roszkowski K, Pluzanska A, Krzakowski M, Smith AP, Saigi E, Aasebo U, et al. A multicenter, randomized, phase III study of docetaxel plus best supportive care versus best supportive care in chemotherapy-naive patients with metastatic or non-resectable localized non-small cell lung cancer (NSCLC). Lung Cancer. 2000;27:145-57.


November 2022 Modified Cycle Frequency section


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M - Disclaimer

Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph.  Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.