Extract from a document

THE CANBERRA HOSPITAL
HAEMATOLOGY/ONCOLOGY
MEDICAL ONCOLOGY
Protocol Number: MO-NEURO-1
Issue No: 1
Issue Date Jan 2001
Authorised by: Dr Paul Craft

Temozolomide

READERS PLEASE NOTE THAT
THIS NOT AN OFFICIAL COPY.
IT MAY NOT BE UP TO DATE AND MUST NOT BE RELIED UPON.

 

USUAL INDICATION
Front line palliative chemotherapy for relapsed or persistent glioblastoma multiforme and anaplastic astrocytoma following standard therapy including radiotherapy.

PROTOCOL SCHEDULE
Temozolomide (no prior chemotherapy) .............200mg/m2 d1-5
[note- this means dose relates to body surface area - the doctor has a special little slide rule to make the calculation, into which weight and height are entered]

OR

Temozolomide (prior chemotherapy) ..................150mg/m2 d1-5

Repeat every four weeks (28 days). At least six cycles are recommended in responding patients although up to two years treatment has been adminstered in clinical trials.

NOTES
• Capsules must be taken in a fasting state with water. Patients should avoid food for a minimum of 1 hour post treatment. Dosing in the mornings after an overnight fast is recommended.
• Temozolomide may cause myelosuppression (nadir day 20-28), nausea, vomiting and fatigue.
• Use caution if serum creatine >1.5 times upper limit of normal (see dose adjustment).

DOSE MODIFICATION/REDUCTION
Dose modification is based on day 1 FBC and day 21 FBC and serum creatinine.
Treatment should be delayed if the day ANC<1,500 OR the day 1 platelet count is <100,000.
DOSE ADJUSTMENT should be based on the day 21 (of a 28 day cycle) FBC according to the attached schedule.

RECOMMENDED ANTI-EMETIC PROTOCOL
Recommended anti-emetic protocol is a 5HT3 antagonist.

REFERENCE
Yung A, Levin VA, Albright et. al. Randomised trial of Temodal vs procarbaziine in glioblastoma multiforme at first relapse. Proc ASCO, abstract 532, 1999.

Dosage Adjustment Based on DAY 21 FBC

Toxicity level (CTC)
ANC/mm3
Platelets/mm3
Temozolomide Modification
0
>2000
>100,000
No change
1
1500-1999
75-99,000
No change
2
1000-1499
50-74,000
No change
3
500-999
25-49,999
Decrease dose one level
4
<500
<25,000
Decrease dose one level

If the serum creatinine is >2 times upper limit of normal, decrease dose by one dose level.

Dose levels (daily dose):
1. 200mg/m2/day
2. 150mg/m2/day
3. 100mg/m2/day

Dose escalation should not be attempted except for pateints treated with 150mg/m2/day on cycle one because of a history of prior chemotherapy. If no grade 2 or greater myelosuppression occurs in cycle one dose escalation to 200mg/m2/day is appropriate.

In addition to dose adjustment based on day 21 FBC treatment should be delayed until the day 1 FBC is satisfactory (see dose modification/reduction).

REPEAT WARNING
This is an extract from a hospital treatment protocol dated January 2001.
It may not be up to date and must not be relied upon.

Notes - not from the protocol text:
---- 1: ANC = total white blood cells
---- 2: creatine - this reference is only relevant where the person has prior history of kidney disease