Phase II study of a Combination of Paclitaxel and 5'-DFUR in Patients with S-1 Failure Unresectable or Recurrent Gastric Cancer

Phase II study of a Combination of Paclitaxel and 5'-DFUR in Patients with S-1 Failure Unresectable or Recurrent Gastric Cancer - Phase II study of a Combination of Paclitaxel and 5'-DFUR in Patients with S-1 Failure Unresectable or Recurrent Gastric Cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008632

Enrollment

Registered

2012-08-06

Start date

2007-10-01

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 or recurrent gastric cancer previously treated with S-1

Interventions

The treatment included PTX 70 mg/m2 i.v. on days 1, 8, and 15 every 4 weeks and 5&#39

-DFUR 600 mg/body p.o. everyday

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically proven unresectable or recurrent gastric cancer showing resistance to S-1. 2) ECOG Performance status:0-2 3) Up to one prior chemotherapy 4) 4 weeks rest after prior chemotherapy 5) Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors. (RECIST) 6) Adequate organ functions: i) hemoglobin >=9.0g/dL, ii) WBC >=4000/mm3, iii) neutrophils >=2000/mm3, iv) platelets >=100,000/mm3, v) AST(GOT)/ALT(GPT) <=2.5 X UL, vi) total bilirubin <=1.5mg/dL, vii) creatinine <=1.5mg/dL, 7) Life expectancy of more than 3 months 8) Age greater than 20 9) Informed consent approved by IRB

Exclusion criteria

Exclusion criteria: 1) Drug hypersensitivity. 2) Infection and inflammation. 3) Prior infusion of paclitaxel 4) Peripheral neuropathy 5) Active synchronous malignancy. 6) Brain metastasis. 7) Severe mental disorders. 8) Symptomatic pulmonary fibrosis or interstitial pneumonia. 9) Severe systemic edema. 10) A large amount of pleural effusion or peritoneal fluid. 11) Severe heart disease. 12) Myocardial infarction within six months. 13) DM with insulin injection. 14) Pregnant patient

Design outcomes

Primary

Measure	Time frame
Response Rate	—

Secondary

Measure	Time frame
Overall survival(OS), Progression-free survival(PFS), Time to Treatment Failure(TTF), Adverse Effect, QOL	—

Countries

Japan

Contacts

Public ContactShigefumi Yoshino

Yamaguchi University Graduate School of Medicine Department of Digestive Surgery and Surgical Oncology

sigefumi@yamaguchi-u.ac.jp0836-22-2264

Outcome results

None listed

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

Phase II study of a Combination of Paclitaxel and 5&#39;-DFUR in Patients with S-1 Failure Unresectable or Recurrent Gastric Cancer