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. Author manuscript; available in PMC: 2010 Jan 29.
Published in final edited form as: Cancer Chemother Pharmacol. 2008 Mar 5;63(1):65. doi: 10.1007/s00280-008-0712-z

Table 1.

PI-88 dose-escalation scheme

Cohort PI-88 (mg) administered
subcutaneously for
4 days weekly		 Docetaxel (mg/m2) administered
intravenously weekly for
three out of four weeks		 Number
of patients		 Number of cycles
of therapy
1 106 30 3 6
2 140 30 3 5
3 190 30 3 8a
4 250 30 7c 23b
Total 16 42
a

One patient in this cohort received PI-88 alone for cycle 2 day 15. Docetaxel was withheld due to grade 1 hyperbilirubinemia possibly related to treatment

b

One patient in this cohort continued with stable disease after the end of cycle 6 and was transferred to the continuation protocol alone for two further cycles (included in the total number of cycles above)

c

One patient developed rapid progression of disease with new brain metastases after cycle 1 day 5; therefore, this patient was not included for assessment of response and was replaced and not included in the assessment of number of cycles in this table; however, this patient was included for assessment of toxicity