#3

SUMMARY OF CHANGES
RTOG 95-07 Topotecan October 25, 1996



The following changes are in effect:

Dose level 3 (1.5 mg/m2 per day) is open for accrual.

There was no dose-limiting toxicity observed at the 1.0 mg/m2 dose arm. Please remember to obtain and monitor CBC and differentials: before each cycle of topotecan; weekly while on treatment; weekly for 3 weeks after third cycle of topotecan; every two days if grade 4 hematologic toxicity is observed until recovery. There is no routine use of G-CSF to treat or prevent hematologic toxicity (may use at investigator's discretion to treat grade 4 neutropenia lasting more than 7 days or septic neutropenia).

Ten evaluable patients, or a maximum of 15 total patients, will be accrued to the third dose level.

Replacement pages are attached.