No. of Patients 
Re-evaluate if the Response 
Rate is Less Than 
6- 9 
1 
10 - 13 
2 
14 - 16 
3 
17-20 
4 
Using a significance test of a = 0.05, we will use the following table to stop 
the study for unacceptable toxicity. 
No. of Patients 
Re-evaluate if Number 
of "Successes" is Less 
Than 
6-7 
4 
8 
5 
9 
6 
'Success is defined as completion of therapy without death. 
9.0 DRUG INFORMATION 
9.1 Carboplatin (CBDCA) NSC #241240 
It is a bifunctional alkylating agent and is non-phase specific. Carboplatin 
appears to bind to cellular replicating DNA and to alter the superhelical 
conformation resulting in single strand breaks. The half-life of total and of 
free platinum is 306 times longer after carboplatin than it is after cisplatin. 
The drug is commercially available and supplied in 20 ml vials containing 150 
mg of carboplatin prepared as a white lyophilized powder and 150 mg of 
mannitol. Intact vials should be stored under refrigeration (2-8 'C) and 
reconstituted with 9.8 ml sterile water, each ml containing 15 mg carboplatin 
and 15 mg mannitol at pH 4.5-7.0. When reconstituted as directed, the 
solution of carboplatin exhibits no decomposition for at least 24 hours at room 
temperature (22-25 • C). Further dilution to a concentration of approximately 
[722] 
Recombinant DNA Research, Volume 14 
