Phase II evaluation of low-dose continuous 5-fluorouracil and weekly cisplatin in advanced adenocarcinoma of the stomach. A Southwest Oncology Group study.
We have conducted a Phase II trial in patients with metastatic gastric cancer utilizing low-dose continuous infusion 5-fluorouracil (5FU) and weekly cisplatin (CDDP). The 5FU was administered at a dose of 200 mg/m2 per day by 24-hour continuous infusion via a permanent central venous catheter. The CDDP was administered at a dose of 20 mg/m2/week for the first 8 weeks, then every other week thereafter. Patients were evaluated for response every 8 weeks. There were 2 complete and 2 partial responses out of 39 eligible and evaluable patients for an overall response rate of 10% (95% CI = 3-24%). The primary toxicities were nausea, hyponatremia, and anemia. Overall, treatment was well tolerated. We conclude that, although the treatment is relatively well tolerated, the regimen has minimal activity in this disease and does not deserve further study.
University of Kansas Medical Center, Division of Clinical Oncology, Kansas City 66160-7353, USA.
S K
SK
Williamson
C M
CM
Tangen
A M
AM
Maddox
C H
CH
Spiridonidis
J S
JS
Macdonald
D000230:Adenocarcinoma / Q000188:drug therapy*; D000740:Anemia / Q000139:chemically induced; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007010:Hyponatremia / Q000139:chemically induced; D007262:Infusions, Intravenous; D009325:Nausea / Q000139:chemically induced; D012074:Remission Induction; D013274:Stomach Neoplasms / Q000188:drug therapy*; D014481:United States
D000964:Antimetabolites, Antineoplastic; D002945:Cisplatin; D005472:Fluorouracil