Table A8.
Toxicity Grade | Dose Interruption | Dose Modification | Dose for Subsequent Cycles |
---|---|---|---|
0-2 | Treat on time | No change | Initiate phosphorous replacement and repeat phosphorous approximately every 3 to 5 days until within normal limits |
3 or 4 | Delay until < grade 2* | Reduce 1 dose level | If toxicity remains < grade 2, dose re-escalation can be considered at discretion of treating investigator; if dose is re-escalated and grade 4 toxicity recurs, institute permanent dose reduction† |
Patients requiring delay of > 4 weeks should go off protocol therapy.
Dose reductions below dose level − 3 were not allowed; if dose reductions below dose level − 3 were required, study drug administration was discontinued.