A Phase II study of irinotecan in combination with 120-h infusion of 5-fluorouracil in patients with metastatic colorectal carcinoma: Japan Clinical Oncology Group Study (JCOG9703).
OBJECTIVE
To evaluate the antitumor effect and feasibility of a combination of irinotecan (CPT-11) and 5-day infusional 5-fluorouracil (5-FU) in a sequential schedule based on our previous combination phase I studies in patients with metastatic colorectal cancer.


METHODS
Forty chemotherapy-naive patients with metastatic colorectal cancer received 90-min infusion of CPT-11 at a dose of 150 mg/m(2) on days 1 and 15 and 120-h protracted infusion of 5-FU at 600 mg/m(2)/day on days 3-7, which were repeated every 4 weeks.


RESULTS
The median number of actually administered courses was five, ranging from one to 14. There were 16 (40%) patients who developed grade 3 or 4 neutropenia. Grade 3 or 4 nausea/vomiting and diarrhea were seen in three (8%) and seven (18%) patients, respectively. Only one early death not related to treatment occurred during the study. There was one complete response and 17 partial responses with a response rate of 45% (95% confidence interval: 29.3-61.5%). With a median follow-up period of 22.5 months for survivors, the median survival and median progression-free survival times were 15.9 and 7.0 months, respectively.


CONCLUSIONS
Although the toxicities were modest, this sequentially combined regimen is active and feasible in patients with metastatic colorectal cancer.
Ohtsu
Atsushi
A
Division of Gastrointestinal Oncology/Digestive Endoscopy, National Cancer Center Hospital East, Kashiwanoha, Kashiwa, Japan. aohstu@east.ncc.go.jp
Boku
Narikazu
N
Yoshioka
Takashi
T
Hyodo
Ichinosuke
I
Shirao
Kuniaki
K
Shimada
Yasuhiro
Y
Saitoh
Soh
S
Nakamura
Akira
A
Yamamichi
Noboru
N
Yamamoto
Seiichiro
S
Yoshida
Shigeaki
S
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D003110:Colonic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000473:pathology
D000077146:Irinotecan; D005472:Fluorouracil; D002166:Camptothecin