Table 3.

Summary of DLTs and previous irinotecan-based therapy

Cohort (patients)IrinotecanFlavopiridolPts with DLTToxicityPrior irinotecan therapy (irinotecan dose)Toxicity with previous irinotecan schedule
Cohort 5 (5)1007034 of 6IFL* (125 mg/m2 weekly)None
G 3 diarrheaIFL (125 mg/m2 weekly)None
4 of 6IFL (125 mg/m2 weekly)Full records unavailable—tolerated by patient report
Cohort 6 (6)125501G 3 fatigue and diarrheaIFL (100 mg/m2 weekly)Grade 3 fatigue and diarrhea
Cohort 7a (6)125602G 3 fatigue and G 3 hyperbilirubinemiaIFL (?dose)Full records unavailable—tolerated by patient report
G 3 fatigue, 4 of 6IFL (125 mg/m2 weekly)None
Cohort 7b (6)1256024 of 6Nonen/a
4 of 6IFL (100 mg/m2 weekly)None
Cohort 8 (9)1006034 of 6Nonen/a
G 4 neutropeniaNonen/a
G 4 neutropenia + feverIrinotecan 80 mg/m2 weekly (3 on/1 off) + IHA FuDRNone
  • * IFL: irinotecan 100-125 mg/m2, fluorouracil 500 mg/m2, leucovorin 20 mg/m2 weekly for 4 weeks followed by a 2-week break.

  • IHA FuDr: intrahepatic pump chemotherapy with floxuridine.