Phase II study of protracted irinotecan infusion and a low-dose cisplatin for metastatic gastric cancer.
OBJECTIVE
To test protracted irinotecan infusion plus a low-dose cisplatin in this Phase II trial to decrease its toxicity.


METHODS
The eligibility criteria were: (1) histologically proven measurable gastric cancer; (2) performance status of 0 or 1; (3) no prior chemotherapy or completion of prior therapy at least 4 wk before enrollment; (4) adequate function of major organs; (5) no other active malignancy; and (6) written informed consent. The regimen consisted of irinotecan (60 mg/m(2)) on d 1 and 15 by 24-h infusion and cisplatin (10 mg/m(2)) on d 1, 2, 3, 15, 16, and 17. Treatment was repeated every 4 wk.


RESULTS
Thirty-one patients were registered between April 2000 and January 2001. The response rate for all 31 patients, 20 patients without prior chemotherapy, and 11 patients with prior chemotherapy was 52% (16/31), 60% (12/20), and 36% (4/11), respectively. The median survival time was 378 d. The median number of courses given to all patients was 2. Grade 4 neutropenia occurred in 11 (35%) patients, while grade 3 to 4 diarrhea or nausea occurred in 1 (3%) and 3 (10%) patients, respectively. Fatigue was minimal as grade 1 fatigue was found only in 3 (10%) patients. Other adverse events were mild and no treatment-related deaths occurred.


CONCLUSIONS
This regimen showed a high level of activity and acceptable toxicity in patients with metastatic gastric cancer.
Imamura
Hiroshi
H
Department of Surgery, Sakai Municipal Hospital, 1-1-1, Minamiyasui-cho, Sakai, Osaka 590-0064, Japan. imamura-h@city.sakai.osaka.jp
Ikeda
Masataka
M
Furukawa
Hiroshi
H
Tsujinaka
Toshimasa
T
Fujitani
Kazumasa
K
Kobayashi
Kenji
K
Narahara
Hiroyuki
H
Kato
Michio
M
Imamoto
Haruhiko
H
Takabayashi
Arimichi
A
Tsukuma
Hideaki
H
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; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis / Q000188:drug therapy*; D013274:Stomach Neoplasms / Q000188:drug therapy*; D015996:Survival Rate; D016896:Treatment Outcome
D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin