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A - Regimen Name

DOCEGEMC Regimen
Gemcitabine-DOCEtaxel


Disease Site
Gynecologic - Uterine Sarcoma
Sarcoma - Soft Tissue
Sarcoma - Uterine

(Metastatic Uterine Leiomyosarcoma)


Intent
Palliative
Adjuvant

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.

 
B - Drug Regimen

gemcitabine
900 mg /m² IV over 30 to 90* minutes Days 1 and 8
DOCEtaxel
100 mg /m² IV Day 8

(*Some clinical trials used an infusion rate of 10 mg/m2/min.) (Continued on next page)

 Reduce dose for patients with prior radiation therapy:

gemcitabine
650 mg /m² IV over 30 to 65* minutes Days 1 and 8
DOCEtaxel
75 mg /m² IV Day 8

(*Clinical trials used an infusion rate of 10 mg/m2/min)

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C - Cycle Frequency

REPEAT EVERY 21 DAYS

Until disease progression or unacceptable toxicity

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Low

Other Supportive Care:

  • Dexamethasone 8 mg bid po for 3 days starting 1 day prior to docetaxel (prevent anaphylaxis / fluid retention).
  • Some clinical trials have used filgrastim on days 9 to 16.  Hematological toxicity is common; consider the use of granulocyte growth factor (G-CSF). If G-CSF is not available, consider prophylactic antibiotics or dose reduction. 
 
E - Dose Modifications

Doses should be modified according to the protocol by which the patient is being treated. The following recommendations have been adapted from clinical trials or product monographs and could be considered.

 

 

Dosage with toxicity

Dosing based on worst toxicity in previous cycle:

Non-Hematologic Toxicity
 
Hematologic Toxicity
 
Gemcitabine
(% Full Dose)
DAY 8 Docetaxel (% full dose)
Grade 3
or
Grade 4 neutropenia ≥ 7 days
or
Febrile neutropenia
or
Thrombocytopenic bleeding 
 
 
75%*
 
75%*
Discontinue if recurs

Grade 3 neurotoxicity

 
 
100%*
75%*, Discontinue if recurs
Any occurrence of cystoid macular edema     No change Hold and investigate; refer patient promptly to an ophthalmic examination. Discontinue if confirmed.
  • Pneumonitis
  • Hemolytic Uremic Syndrome (HUS)
  • Stevens-Johnson syndrome (SJS)
  • Toxic epidermal necrolysis (TEN)
  • Capillary Leak Syndrome (CLS)
  • Grade 4 neurotoxicity
 
 
Discontinue
 
 
 
 
 
 
 
Discontinue
Non-Hematologic Toxicity (Continued)   Hematologic Toxicity (Continued)

Gemcitabine
(% Full Dose)

Day 8 DOCEtaxel
(% Full Dose)

 Grade 4 other toxicity

 
 
 
Discontinue,
or ↓ to 75%*
Discontinue,
or ↓ to 75%*

Day 8 holds on > 1 cycle

 
Discontinue,
or ↓ to 75%*
100%*
*Do not start new cycle until ANC ≥ 1500x 106/L, platelets ≥ 100,000 x 106/L and non-hematologic toxicity ≤ grade 2.

On Day 8 of Cycle:

Toxicity on Day 8 of cycle
 
Non- Hematologic
 
Hematologic
Day 8 Gemcitabine (% Full Dose)
Day 8 Docetaxel (% Full Dose)
 
 
AGC
(x 106/L)
 
Platelets
(x 106/L)
 
 
≤ grade 2
and
> 1000
and
> 100,000
100%
100%
≤ grade 2
and
500-1000
 
or
50,000-100,000
Omit, or  ↓ to  75%
Omit
Grade 3 or 4
or
< 500
or
< 50,000
Omit, ↓ to 75%
at restart  (if applicable) for non-hematologic toxicity
Omit
Pneumonitis,
HUS,
SJS,
TEN,
CLS,
Grade 4 neurotoxicity
 
-
 
 
Discontinue
 
 
Discontinue



Hepatic Impairment

 
AST and/or ALT
 
Alk Phosp
 
Bilirubin
Gemcitabine
Docetaxel   dose
Mild-moderate
> 1.5 X ULN
AND
> 2.5 x ULN
 
 
Use with caution
Do not treat
Severe
> 3.5 x ULN
OR
> 6 x ULN
OR
> ULN
Consider ↓ or Discontinue
Do not treat. Discontinue if treatment already started.

Renal Impairment

Drug
Renal Impairment
Gemcitabine
Use with caution; close monitoring for occurrence of hemolytic uremic syndrome is required. No specific recommendations found
Docetaxel
No dose adjustment required

Dosage in the Elderly

For gemcitabine, clearance is lower in the elderly but no dose adjustment necessary.

For docetaxel, no adjustment required, but caution should be exercised in elderly patients with poor performance status.

 


 
F - Adverse Effects

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

 

 


Most Common Side Effects 

Less Common Side Effects, but may be
Severe or Life-Threatening

  • Myelosuppression ± infection or bleeding (may be severe)
  • Hypersensitivity reactions (may be severe)
  • Fatigue, flu-like symptoms
  • Fluid retention (may be severe)
  • Neuropathy (motor or sensory)
  • Cutaneous effects (including nails, may be severe)
  • Alopecia
  • Proteinuria
  • GI (stomatitis, nausea/vomiting, diarrhea)
  • Musculoskeletal pain
  • ↑ LFTs (may be severe)
  • Lacrimation/tear duct obstruction
  • Secondary malignancies
  • Pneumonitis/ARDS
  • Capillary leak syndrome
  • Cardiotoxicity, arrhythmia
  • Venous thromboembolism
  • Arterial thromboembolism
  • DIC
  • Seizures
  • Hemolytic uremic syndrome
  • Vasculitis
  • GI obstruction, perforation
  • Cystoid macular edema
 
G - Interactions

Refer to gemcitabine, DOCEtaxel drug monograph(s) for additional details


Gemcitabine is a known radiosensitizer.

 
H - Drug Administration and Special Precautions

Refer to gemcitabine, DOCEtaxel drug monograph(s) for additional details


 

 

 
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; at each visit
  • Liver function tests; baseline and regular
  • Renal function tests; baseline and regular
  • Clinical toxicity assessment, including infection, bleeding, neurotoxicity, fatigue, fluid retention, flu-like symptoms, hypersensitivity, cutaneous changes, thromboembolism, ophthalmic, cardiovascular, musculoskeletal pain, GI or pulmonary effects; 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
Day 1: 0.75 hour; Day 8: 2 to 3 hours
Pharmacy Workload (average time per visit)
29.323 minutes
Nursing Workload (average time per visit)
47.917 minutes
 
K - References

Docetaxel and gemcitabine drug monographs, Cancer Care Ontario.

Hensley ML, Blessing JA, DeGeest K, et al. Fixed-dose rate gemcitabine plus docetaxel as second-line therapy for metastatic uterine leiomyosarcoma: A Gynecologic Oncology Group phase II study. Gyne Oncol 2008;109:323-8.

Hensley ML, Blessing JA, Mannel R, Rose PG. Fixed-dose rate gemcitabine plus docetaxel as first-line therapy for metastatic uterine leiomyosarcoma: a Gynecologic Oncology Group phase II trial. Gynecol Oncol 2008 Jun;109(3):329-34.

Hensley ML, Maki R, Venkatraman E, Geller G, Lovegren M, Aghajanian C, et al. Gemcitabine and docetaxel in patients with unresectable leiomyosarcoma: results of a phase II trial. J Clin Oncol 2002;20:2824-31.

Pautier P, Floquet A, Penel N, et al. Randomized multicenter and stratified phase II study of gemcitabine alone versus gemcitabine and docetaxel in patients with metastatic or relapsed leiomyosarcomas: a Federation Nationale des Centres de Lutte Contre le Cancer (FNCLCC) French sarcoma group study (TAXOGEM study). Oncologist 2012;17(9):1213-20.


December 2017 added infusion time for gemcitabine


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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.
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