Phase I study of a weekly schedule of fixed-dose paclitaxel and escalating doses of cisplatin for recurrent or unresectable gastric cancer in Japan

Am J Clin Oncol. 2005 Jun;28(3):242-7. doi: 10.1097/01.coc.0000158437.92000.e7.

Abstract

The authors objective was to determine the toxicities and maximum tolerated dose of a dose-dense schedule of fixed-dose paclitaxel and escalating doses of cisplatin in patients with recurrent or unresectable carcinoma of the stomach. On days 1, 8, 15, 29, 36, and 43, patients received a fixed dose of paclitaxel (80 mg/m2 over 1 hour after a short premedication) followed by a 30-minute infusion of cisplatin at dose levels of 7, 15, 20, and 25 mg/m2. Six patients were treated at each dose level, except for the dose of 25 mg/m2 cisplatin. All the patients were assessed for toxicity and 17 patients (81%) were evaluated for response. The cisplatin dose could be escalated to 25 mg/m2. At the dose of 80 mg/m2 paclitaxel and 25 mg/m2 cisplatin, all 3 patients developed dose-limiting toxicity of the gastrointestinal tract. There were no treatment-related deaths. Leukopenia grades 3 or 4 was seen in 5 patients (11.1%), but infectious complications were not encountered. Other toxicities were mild and easily managed. Weekly paclitaxel at a dose of 80 mg/m2 infused over 1 hour, followed by an infusion of 20 mg/m2 cisplatin is recommended for further study in patients with recurrent or unresectable gastric cancer.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Carcinoma / drug therapy*
  • Carcinoma / secondary
  • Carcinoma / surgery
  • Cisplatin / administration & dosage
  • Cisplatin / adverse effects
  • Combined Modality Therapy
  • Drug Administration Schedule
  • Feasibility Studies
  • Female
  • Gastrectomy
  • Gastrointestinal Diseases / chemically induced
  • Humans
  • Infusions, Intravenous
  • Japan
  • Leukopenia / chemically induced
  • Male
  • Middle Aged
  • Neoplasm Recurrence, Local / drug therapy
  • Nervous System Diseases / chemically induced
  • Paclitaxel / administration & dosage
  • Paclitaxel / adverse effects
  • Peritoneal Neoplasms / drug therapy
  • Peritoneal Neoplasms / secondary
  • Stomach Neoplasms / drug therapy*
  • Stomach Neoplasms / surgery
  • Treatment Outcome

Substances

  • Paclitaxel
  • Cisplatin