Phase I study of weekly cisplatin, bolus fluorouracil and escalating doses of irinotecan in advanced solid tumors.
OBJECTIVE
We performed a phase I study of 5-fluorouracil (5-FU), cisplatin and irinotecan.


METHODS
Twenty-nine patients received cisplatin 25 mg/m(2) and bolus 5-FU 425 mg/m(2), along with irinotecan at 40, 50, and 65 mg/m(2) weekly for 4 out of 6 weeks.


RESULTS
The maximum tolerated dose (MTD) for untreated patients was irinotecan 65 mg/m(2) while the MTD for previously treated patients was irinotecan 40 mg/m(2). Neutropenia and diarrhea were the major dose-limiting toxicities. Antitumor activity was noted in gastric, esophageal and pancreatic cancers.


CONCLUSIONS
Because of the toxicity profile, combinations with continuous infusion 5-FU or capecitabine should be explored.
Ku
Geoffrey Y
GY
Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10065, USA.
O'Reilly
Eileen M
EM
Saltz
Leonard B
LB
Schrag
Deborah
D
Maki
Robert G
RG
Kelsen
David P
DP
Ilson
David H
DH
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D002945:Cisplatin / Q000008:administration & dosage; D003967:Diarrhea / Q000139:chemically induced; D004067:Digestive System Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D004334:Drug Administration Schedule; D004938:Esophageal Neoplasms / Q000188:drug therapy; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007262:Infusions, Intravenous; D007275:Injections, Intravenous; D000077146:Irinotecan; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D010190:Pancreatic Neoplasms / Q000188:drug therapy; D013274:Stomach Neoplasms / Q000188:drug therapy; D013997:Time Factors; D016896:Treatment Outcome
D000077146:Irinotecan; D002945:Cisplatin; D005472:Fluorouracil; D002166:Camptothecin