C.
FUDR DOSE MODIFICATION SCHEMA
SGOT Ref. value:
< 50 u/l
> 50 u/l
SGOT at pump emptying or day of planned
retreatment (whichever is higher)
0 to <3 X ref
0 to <2 X ref
100%
3 to <4 X ref
2 to <3 X ref
80%
4 to <5 X ref
3 to <4 X ref
50%
>4 X ref
HoldA
>5 X ref
ALK PHOS Ref. value:
< 90 u/l
> 90 u/l
ALK PHOS at pump emptying or day of planned
retreatment (whichever is higher)
TOT BILI Ref. value:
FUDR Dose
FUDR Dose
0 to <1.5 X ref
0 to <1.2 X ref
100%
1.5 to <2 X ref
1.2 to <1.5 X ref
50%
>2.0 X ref
>1.5 X ref
HoldB
< 1.2 mg/dl
> 1.2 mg/dl
TOT BILI at pump emptying or day of planned
retreatment (whichever is higher)
FUDR Dose
0 to <1.5 X ref
0 to <1.2 X ref
100%
1.5 to <2 X ref
1.2 to <1.5 X ref
50%
>2.0 X ref
>1.5 X ref
HoldC
"Reference value" is defined as the value obtained on the day patient received last FUDR dose. To determine
if an FUDR dose modification is necessary, compare reference value to either the value obtained on day
pump was emptied or that obtained on day of planned pump filling, whichever is higher. NOTE: Increased
value must be higher than the upper limit of institutional normal laboratory value before dose
modifications are implemented.
RECOMMENCING TREATMENT AFTER HOLD
A
SGOT
After treatment has been held due to elevated SGOT, chemotherapy cannot be restarted until value
has returned to within 4 X reference value (if reference <50 u/l) or within 3 X reference value (if
reference >50 u/l). Then chemotherapy may be restarted, using 50% of the last FUDR dose given.
BALK
PHOS After treatment has been held due to elevated alkaline phosphatase, chemotherapy cannot
be restarted until value has returned to within 1.5 X reference value (if reference <90u/l)
or within 1.2 X reference value (if reference >90u/l). Then chemotherapy may be
restarted, using 25% of the last FUDR dose given.
CTOT
BILI
NOTE:
After treatment has been held for elevated total bilirubin, chemotherapy cannot be restarted until
value has returned to within 1.5 X reference value (if reference <1.2 mg/dl) or within 1.2 X
reference value (if reference >1.2 mg/dl). Then chemotherapy may be restarted, using 25% of
the last FUDR dose given.
IF TOTAL BILIRUBIN BECOMES ELEVATED OVER 2.0 mg/dl,
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the pump should be emptied and chemotherapy held until the bilirubin
returns to  1.5md/dl. At this time chemotherapy may be resumed using
25% of the last FUDR dose administered. FUDR can be continued as
long as the bilirubin remains  1.5md/dl. If the patient develops a total
bilirubin greater than 3.0mg/dl, the pump should be emptied and
Dexamethasone 20mg plus heparinized saline should be placed in the pump for 14 days.
Once there is no longer evidence of toxicity, Dexamethasone dose should be tapered in
increments of 2mg every 14 days. (If the highest bilirubin was less that 5.0mg/dl,
Dex may be tapered in increments of 5mg) Tapering should continue unless there is evidence of
disease progression (increasing CEA, worsening CT scan and clinical status).
Questions concerning pump filling and emptying may be directed to
Codman 1-800-660-2660
a Johnson & Johnson company
D. GENERAL RULES:
1.
If a patient has a sudden change in condition, liver function tests should immediately be checked and the
pump emptied of chemotherapy if there is any suspicion of drug-induced toxicities.
2.
Should epigastric pain develop and is unresponsive to oral H 2 blocker use is suggestive of gastroduodenal
irritation or ulcer. Severe pain should prompt workup with an upper gastrointestinal endoscopy. Serum
amylase should be checked along with the routine bloods (screening profile, creatinine, and CBC) in patients
with abdominal pain. If an ulcer or gastroduodenitis is documented, therapy should be held for one month to
allow healing. If abdominal pain is severe, the pump should be emptied of FUDR until results of workup are
available.
3.
Monitor patient for signs of toxicity related to chemotherapy.


4.
FUDR: gastritis, gastroduodenal ulcers, chemical hepatitis, sclerosing cholangitis with jaundice,
pruritus, diarrhea.
Dex: sodium retention, fluid retention, hypertension, development of cushingoid state, secondary
adrenocortical and pituitary hypo-responsiveness, decreased carbohydrate tolerance, manifestations of
latent diabetes.
Complications related to the pump catheters

Infection, hepatic artery thrombosis, pump malfunction, catheter occlusion, intra-abdominal bleed.
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