Randomized phase III study of CPT-11 versus Weekly Paclitaxel for unresectable or recurrent gastric cancer refractory to combination chemotherapy with fluoropyrimidine plus platinum.

Randomized phase III study of CPT-11 versus Weekly Paclitaxel for unresectable or recurrent gastric cancer refractory to combination chemotherapy with fluoropyrimidine plus platinum. - WJOG4007

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001252

Enrollment

220

Registered

2008-07-15

Start date

2007-08-01

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

unresectable or recurrent gastric cancer refractory to combination chemotherapy with fluoropyrimidine plus platinum

Interventions

CPT-11 Paclitaxel

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically proven gastric adenocarcinoma 2.unresectable or recurrent gastric cancer refractory to one prior chemotherapy with fluorouracil plus platinum 3.No prior therapy of Taxane or CPT-11 4.No severe peritoneal metastasis 5.Age 20-75 years old 6.PS 0-2 7.>14 days after prior chemotherapy 8.no history of chemotherapy for other malignancy and radiation to abdomen 9.Adequate organ functions a) WBC>3000/mm3 and <12000/mm3 b) Hb>8.0g/dL c) Plt>10*104/mm3 d) AST.ALT<100IU/L e) T-Bil<1.5mg/dL f) Cre<1.5mg/dL 10.HBV(-) 11.Written informed consent

Exclusion criteria

Exclusion criteria: 1.Serious medical condition such as infection, heart disease 2.Massive pleural effusion or ascites or pericardial effusion 3.Hypersensitivity or neuropathy 4.Interstitial pneumonia 5.CNS metastasis 6.Pregnancy or breast-feeding

Design outcomes

Primary

Measure	Time frame
overall survival	—

Secondary

Measure	Time frame
response rate, progression free survival, toxicity, rate of subsequent chemotherapy	—

Countries

Japan

Contacts

Public ContactShinichiro Nakamura

West Japan Oncology Group WJOG datacenter

datacenter@wjog.jp06-6633-7400

Outcome results

None listed

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