Phase 1 trial of intraperitoneal paclitaxel in combination with intravenous cisplatin and oral capecitabine in patients with advanced gastric cancer and peritoneal metastases (IPGP study)

Sina Vatandoust, Tim Bright, Amitesh Chandra Roy, Muhammad Nazim Abbas, David Ian Watson, Susan Gan, Jeff Bull, Michael Sorich, Alex Scott-Hoy, Lee Jen Luu, Christos Stelios Karapetis

Research output: Contribution to journalArticlepeer-review

Abstract

Aims: Gastric cancer with peritoneal involvement has a poor prognosis. Intraperitoneal (IP) paclitaxel has shown promising results in these patients. However, this approach has only been studied in the Asian population, and in combination with S-1. We investigated the maximum tolerated dose of IP paclitaxel, with a standard chemotherapy combination, in the Australian population. Methods: The study of the population included metastatic human epidermal growth factor receptor 2 (HER2) negative gastric adenocarcinoma with peritoneal involvement. Treatment included six 21-day cycles of cisplatin (80 mg/m2 IV, day 1) plus capecitabine (1000 mg/m2 PO BD, days 1–14) plus IP paclitaxel (days 1 and 8). IP paclitaxel doses for cohort 1–3 were 10, 20, and 30 mg/m2, respectively, in a 3 + 3 standard dose-escalation design. Results: Fifteen patients were enrolled of which 6 were female and the median age was 63. Two patients developed dose-limiting toxicities. No grade 4/5 toxicities were recorded. The maximum tolerated dose was not reached. Therefore, as defined by the study protocol, the recommended phase-2 dose for IP paclitaxel was determined to be 30 mg/m2. The 12-month survival rate was 46.7%, and the median survival was 11.5 months (interquartile range [IQR]: 15.3–6.9). Conclusions: IP paclitaxel is safe in combination with cisplatin and capecitabine and the recommended phase-2 dose is 30 mg/m2.

Original languageEnglish
Pages (from-to)404-409
Number of pages6
JournalAsia-Pacific Journal of Clinical Oncology
Volume18
Issue number4
Early online date23 Nov 2021
DOIs
Publication statusPublished - Aug 2022

Keywords

  • clinical trial
  • gastric cancer
  • intraperitoneal infusion
  • paclitaxel
  • peritoneal carcinomatosis
  • phase-1

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