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.

regimen-monograph

A - Regimen Name

FUGEMCLCVR Regimen
Gemcitabine-Fluorouracil-Leucovorin


Disease Site
Gastrointestinal - Hepatobiliary / Liver / Bile Duct
(Cholangiocarcinoma)

Intent
Palliative

Regimen Category
Archived : No longer in use and listed for reference purposes only, although the use of such a regimen may be appropriate in a situation where a Standard Regimen cannot be used for clinical reasons. Note: The Disease Site Group considers this regimen archived. It is listed for historical reference only and is no longer updated.

Rationale and Uses
Treatment of cholangiocarcinoma in patients who are not considered candidates for surgery with curative intent, but who are willing and able to tolerate treatment with chemotherapy
 
B - Drug Regimen

gemcitabine
1000 mg /m² IV Days 1, 8 and 15
leucovorin
25 mg /m² IV Days 1, 8 and 15
fluorouracil
600 mg /m² IV Days 1, 8 and 15

 

 

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C - Cycle Frequency

REPEAT EVERY 28 DAYS

For a usual total of 6 cycles

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Low

 
E - Dose Modifications

Doses should be modified according to the protocol by which the patient is being treated. The following recommendations are in use at some centres.

No dose adjustment required for leucovorin.

 

Dosage with toxicity

 Suggested dose modifications:

Worst Toxicity in Previous Cycle or on any Treatment day

 

Dose for remaining treatment days of current cycle and subsequent cycles*

 
Non-hematologic
 
Hematologic
 
Gemcitabine
(% Full Dose)
 
Fluorouracil
(% Full Dose)
 
 
Grade 2
80%
80%

(For grade 2 hand-foot syndrome, reduce 5FU only)

 
Grade 3
or
Grade 3 or 4 or

Febrile neutropenia, thrombocytopenic bleeding 

 
 
70%*
 
70%*

(For mucositis, diarrhea or hand-foot syndrome, reduce 5FU only)

                   Grade 4
 
 
 

Consider discontinuing,

or ↓ to 70%*

Consider discontinuing,

or ↓ to 70%*

Day 8/15 holds in > 1 cycle

 

Pneumonitis or Hemolytic Uremic Syndrome

 
 
Discontinue
 
Discontinue
 

*Hold treatment until ANC ≥ 1500 x 106/L, platelets ≥ 100,000 x 106/L and non-hematologic toxicity  ≤ grade 2. Discontinue 5FU in the event of cardiac toxicity

 

 



Hepatic Impairment

Bilirubin
 
AST/ALT
Gemcitabine
(% previous dose)
5FU
(% previous dose)
1-2 x ULN
And/or
<2 x ULN
100%
100%
2-4 x ULN
2-5 x ULN
Caution
100%
> 4 x ULN
> 5 x ULN
Caution, consider ↓
Discontinue

Renal Impairment

Creatinine Clearance (mL/min)

Gemcitabine

(% previous dose)

5FU

(% previous dose)

> 60
100%
100%
>40-60
100%
100%
20-40
Caution
Caution
< 20
Consider discontinuing or ↓
Consider discontinuing or ↓

 
F - Adverse Effects
Refer to gemcitabine, leucovorin, fluorouracil drug monograph(s) for additional details of adverse effects

• Bolus 5FU regimens have more myelosuppression and GI effects but less Hand-Foot Syndrome, compared to prolonged infusions.

Most Common Side Effects 

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

·         Myelosuppression

·         Fatigue

·         Rash

·         Gastrointestinal effects (nausea, vomiting, diarrhea, stomatitis)

·         Edema & Proteinuria

·         Elevated LFTs

  • Pneumonitis/ARDS
  • Hemolytic-uremic syndrome
  • Myocardial infarction
  • Arterial and venous thromboembolism

 
G - Interactions
Refer to gemcitabine, leucovorin, fluorouracil drug monograph(s) for additional details

Gemcitabine is a known radiosensitizer.
 
H - Drug Administration and Special Precautions
Refer to gemcitabine, leucovorin, fluorouracil drug monograph(s) for additional details
 
I - Recommended Clinical Monitoring

Recommended Clinical Monitoring

  • CBC on each treatment day. Interim counts should be done in first cycle and repeated if dose modifications necessary.
  • Baseline and regular liver and renal function tests (if severe organ failure suspected)
  • Clinical toxicity assessment (including rash, edema, pulmonary, stomatitis, infection, bleeding and diarrhea).
  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

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J - Administrative Information

Approximate Patient Visit
1.5 hours
 
K - References

Alberts SR, Al-Khatib H, Mahoney MR, Burgart L, Cera PJ, Flynn PJ, et al. Gemcitabine, 5-fluorouracil, and leucovorin in advanced biliary tract and gallbladder carcinoma: a North Central Cancer Treatment Group Phase II Trial. Cancer. 2005;103:111-8.

 

October 2017 Removed archived PEBC link


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L - Other Notes

March 2012:  Modified regimen category

 
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.


Last Updated: July 21, 2026