DERBY-BURTON LOCAL CANCER NETWORK

FILENAME

Gem_Cisp.DOC

CCPG B8
CONTROLLED DOC NO:
CSIS Regimen Name:
GEM_CIS_UR

Gemcitabine + Cisplatin Regimen

Available for Routine Use in
Derby in-patient
Derby day-case
Derby community
Derby out-patient

Burton in-patient
Burton day-case
Burton community
Burton out-patient
Indication
Treatment Intent
Anti-Emetics

Urothelial
Neo-adjuvant or Palliative
Pre-chemotherapy
Day 1
Day 2
Day 8 & 15
Post-chemotherapy
Day 1
Day 8 & 15

2
3
2
C
B

Day 1

Gemcitabine

1000mg/m2

Intravenous infusion in 250ml

sodium chloride 0.9% over 30
minutes

Day 2

Sodium chloride 0.9%

1000ml

Sodium chloride 0.9%

500ml

Mannitol 10%

100ml

Cisplatin

70mg/m2

Mannitol 10%

100ml

Sodium chloride 0.9% +

20mmol magnesium
sulphate + 20 mmol
potassium chloride

1000ml

Intravenous infusion over 1

hour
Intravenous infusion over 30
minutes
(if urine output remains low)
Intravenous infusion over 10
minutes
Intravenous infusion in 1000ml
sodium chloride 0.9% over 60
minutes
(protect infusion from light)
Intravenous infusion over 10
minutes
Intravenous infusion over 2
hours

Gemcitabine

1000mg/m2

Provided
urine output
is
satisfactory
(see notes)

Day 8

DATE OF ISSUE: 23.11.12

REVIEWED BY C.WARD
REVIEW DATE: 23.11.14

Intravenous infusion in 250ml

AUTHORISED BY: Dr P Chakraborti

& Dr P Pattu

*** VALID ON DATE OF PRINTING ONLY ***

VERSION 6
PAGE 1 of 5

DERBY-BURTON LOCAL CANCER NETWORK

FILENAME

Gem_Cisp.DOC

CCPG B8
CONTROLLED DOC NO:
CSIS Regimen Name:
GEM_CIS_UR
sodium chloride 0.9% over 30
minutes

Day 15

1000mg/m2

Gemcitabine

Frequency & duration:

Intravenous infusion in 250ml

sodium chloride 0.9% over 30
minutes

every 28 days for a maximum of 3 cycles (Neo-adjuvant)

every 28 days for a maximum of 6 cycles (Palliative)

Notes:
1.

U&Es, & LFTs must be taken prior to Day 1 of each cycle

2.

FBC must be taken prior to each dose

3.

Following a toxicity assessment each cycle may be given if:

Neutrophils > 1.0x109/L
Platelets
>100x 109/L
If the above parameters are not met see overleaf for details of dose
modifications (incl. days 8 & 15)

4.

The GFR prior to the first treatment should routinely be > 60 ml/minute. Then
prior to each cycle, GFR should be estimated or measured as deemed clinically
appropriate
e.g.

Cockcroft Gault Formula

Females:

1.04 x (140 age) x weight (kg)

serum creatinine (micromol/l)

Males:

1.23 x (140 age) x weight (kg)

serum creatinine (micromol/l)

For patients with body mass index (BMI) of 30 kg/m2 with stable serum
creatinine values, the adjusted body weight (ABW) should be used to
estimate the GFR
i.e.
Ideal Body Weight
Female IBW (kg) = Height in cm - 105
DATE OF ISSUE: 23.11.12
REVIEWED BY C.WARD
REVIEW DATE: 23.11.14

AUTHORISED BY: Dr P Chakraborti

& Dr P Pattu

*** VALID ON DATE OF PRINTING ONLY ***

VERSION 6
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DERBY-BURTON LOCAL CANCER NETWORK

FILENAME

Gem_Cisp.DOC

CCPG B8
CONTROLLED DOC NO:
CSIS Regimen Name:
GEM_CIS_UR

Male IBW (kg) = Height in cm 100

ABW = IBW + 0.4(actual weight IBW
If the estimated serum creatinine clearance is <60 ml/minute, then a formal
measurement of the GFR is required, using either a 24 hour urine collection or
an isotopic clearance. If the isotopic clearance is measured then the value
uncorrected for body surface area (BSA) should be used in dose calculations.
5.

The GFR should be recalculated, or re-measured, for

a. Renal toxicity (CTC Grade 2, serum creatinine >1.5 x ULN),
b. Serum creatinine changes of 10% compared to baseline, or last creatinine
value (whichever is most recent),
c. Cycle 2, if there has been significant doubt about the true GFR at cycle 1
(according to clinical judgement).
Cisplatin Dose Modifications for Impaired Renal Function
Creatinine Clearance (ml/min)
Cisplatin Dose (mg/m2)
100%
60
45-59
50%
<45
Omit

6.

Accurate fluid balance sheet must be kept.

7.

Urine output should be maintained at > 100ml/hour before, during & after
chemotherapy.

8.

Mannitol 10% infusion is the preferred diuretic. If urine output remains

<100ml/hr, a further dose of 100ml may be given by intravenous infusion over
10 minutes. Urine output should increase within 30 minutes of commencing the
infusion. If urine output remains <100ml/hr after 30 minutes, a 10 mg stat IV
bolus of Furosemide may be given to increase urine output. If 30 minutes after
the furosemide dose urine output has still not improved, the Consultant should
be contacted for advice.

9.

Ensure Cisplatin is commenced by 14.00hrs at the latest so an adequate renal

output can be maintained.

DATE OF ISSUE: 23.11.12

REVIEWED BY C.WARD
REVIEW DATE: 23.11.14

AUTHORISED BY: Dr P Chakraborti

& Dr P Pattu

*** VALID ON DATE OF PRINTING ONLY ***

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FILENAME
10.

Gem_Cisp.DOC

CCPG B8
CONTROLLED DOC NO:
CSIS Regimen Name:
GEM_CIS_UR

Dose modifications
Complete ANC and platelet count weekly in every cycle (on day 21 at least during
the first 2 cycles).
Day 1
ANC
Platelets
Gemcitabine/Cisplati
(x 109/L)
(x 109/L)
n
And
Full doses
1.5
100
If a patient needs 2 weeks for haematologic recovery, treatment should be
continued with 75% of all three drugs if WBC 2.0 x 109/L, ANC 1.0 x 109/L and
platelets are 75 x 109/L.
Days 8 & 15
ANC
(x
109/L)
1.5
1.0

And
and

Platelet
s
(x 109/L)
75
50

Percentage dose of
Gemcitabine
100% Dose

100% Dose
or
Withhold
1.0
50
25% dose reduction in both drugs if during the nadir one or more of the following
occurs:
Grade IV neutropenia (ANC 0.5 x 109/L) with fever 38.5C or
Grade IV thrombocytopenia ( 10.0 x 109/L) for more than 3 days or
Thrombocytopenia with active bleeding during the nadir.
If afebrile grade IV neutropenia is present on day 15 give prophylactic ciprofloxacin
500mg twice daily for 7 days.
11.

12.

Mucosal Toxicity
Patients with grade 3 4 mucositis will have a 25% dose decrease of on days 1,
8 & 15.
Neurotoxicity
Grade 3-4 neurotoxicity cisplatin should be discontinued and patients remain in
the protocol as long as they continue to receive gemcitabine and no additional
anti-cancer treatment is given.

DATE OF ISSUE: 23.11.12

REVIEWED BY C.WARD
REVIEW DATE: 23.11.14

AUTHORISED BY: Dr P Chakraborti

& Dr P Pattu

*** VALID ON DATE OF PRINTING ONLY ***

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FILENAME

Gem_Cisp.DOC

13.
Renal Toxicity
GFR (ml/min)
60ml/min
50 59 ml/min
50ml/min

CCPG B8
CONTROLLED DOC NO:
CSIS Regimen Name:
GEM_CIS_UR

% dose of Gemcitabine
100
100
Full dose gemcitabine unless
the CTC grade for Creatinine
is 3 ( 6 x ULN) in which
case omit dose

% dose of Cisplatin
100
100 to be given over 2
days
If GFR 50ml/min
repeat after IV hydration
(max 2 days), if still
50ml/min withhold
during current cycle.

14.
Other Toxicities
Grade 1 2
no dose reductions
Grade 3
50% dose reductions in both drugs
Grade 4
Patient may be withdrawn from the study at the
investigators discretion. If patient continues under
treatment, 50% dose reduction of both drugs should be
considered.
15.

Dosage adjustments in a cycle

If day 1 of the cycle is delayed the cycle will not consider starting until the day
the first dose is actually administered to the patient.
If the day 8 dose is withheld or missed the cycle would continue per protocol
with one dose not given. If day 15 is withheld or missed this would be
considered to be the week of rest. The following week a dose would be
administered if toxicity permits and considered day 1 of the new cycle.
A patient who cannot be administered treatment after a delay of more than 2
weeks from the planned beginning of a new cycle must be discontinued from
protocol treatment.

References:
1.
BA11 Trial Protocol (5th Sept 2002) Version 6.2

DATE OF ISSUE: 23.11.12

REVIEWED BY C.WARD
REVIEW DATE: 23.11.14

AUTHORISED BY: Dr P Chakraborti

& Dr P Pattu

*** VALID ON DATE OF PRINTING ONLY ***

VERSION 6
PAGE 5 of 5