Second Line Chemotherapy for S-1 Refractory Advanced Gastric Cancer

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is compare overall survival of the test arm (CPT-11/S-1 combination) to the control arm (CPT-11 alone) in the subjects with S-1 refractory advanced gastric cancer.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Japan Clinical Cancer Research Organization
• Collaborator: Taiho Pharmaceutical Co., Ltd.
• Treatments: Camptothecin; Irinotecan

Criteria

Inclusion Criteria:

• Histologically proven inoperable advanced gastric adenocarcinoma (including adenocarcinoma of the gastroesophageal junction) or relapse gastric adenocarcinoma

• Subjects must be able to take orally

• Subjects must be confirmed to be PD status by picture diagnosis after first-line chemotherapy using S-1 alone, S-1 + Cisplatinum or S-1 + taxane, except S-1 + CPT-11

• Within 4 weeks from the diagnosis of PD

• Total dosage of S-1 at the first-line is over 2,240mg/m2 in S-1 alone treatment, 1,680mg/m2 in the S-1 combination

• ECOG performance status ≤ 1

• Follow up Age 20 or over

• Life expectancy estimated more than 12 weeks

• Hgb ≥ 8 g/dL, WBC 4,000-12,000/mm3, ANC ≥ 2,000/mm3, platelets ≥ 100,000/mm3

• Creatinine ≤ upper normal limit (UNL)

• Total bilirubin ≤ 1.5 X UNL

• Written informed consent

Exclusion Criteria:

• S-1 + CPT-11 was employed as a first-line

• Any other cytotoxic agents therapy, immuno-therapy, radiation-therapy

• After S-1 adjuvant

• Suspended cases by adverse events by S-1 or S-1 combination

• Excessive amounts of ascites require drainage

• Known brain metastases

• History of hypersensitivity to fluoropyrimidines and CPT-11

• Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant

• Active double cancer

• Gastrointestinal bleeding

• Any subject judged by the investigator to be unfit for any reason to participate in the study