Phase I/II study of intravenous and intraperitoneal paclitaxel combined with continuous intraperitoneal cisplatin for advanced gastric cancer with peritoneal metastasis

Phase I/II study of intravenous and intraperitoneal paclitaxel combined with continuous intraperitoneal cisplatin for advanced gastric cancer with peritoneal metastasis - Phase I/II study of intravenous and intraperitoneal paclitaxel combined with continuous intraperitoneal cisplatin for advanced gastric cancer with peritoneal metastasis

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002257

Enrollment

Registered

2009-08-01

Start date

2009-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced gastric cancer with peritoneal metastasis

Interventions

In the phase I study, paclitaxel is administered intravenously on days 1 and 15 at a fixed dose of 100 mg/m2, and intraperitoneally with an initial dose of 20 mg/m2, stepped up to 30 or 40 mg/m2. Cisp

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histologically proven unresectable or recurrent gastric adenocarcinoma; peritoneal metastasis and/or cancer cells on peritoneal cytology; age more than 20 years; Eastern Cooperative Oncology Group performance status 0-2; adequate bone marrow function (leukocyte count 3,000-12,000/mm3, hemoglobin >8.0 g/dl, platelet count >100,000/mm3); adequate liver function (total serum bilirubin <2.0 mg/dl, serum transaminases <100/UI); adequate renal function (serum creatinine within the upper limit of normal); and an expected survival period of more than 3 months.

Exclusion criteria

Exclusion criteria: Metastasis to distant organ sites (such as the liver, lungs or bone), other active concomitant malignancies, or other severe medical conditions.

Design outcomes

Primary

Measure	Time frame
safety the 1-year overall survival rate	—

Secondary

Measure	Time frame
the overall response rate, efficacy against peritoneal metastasis and safety	—

Countries

Japan

Contacts

Public ContactHironori Ishigami

The University of Tokyo Department of Surgical Oncology

ishigami-tky@umin.net

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026