Status:
COMPLETED
Second Line Chemotherapy for S-1 Refractory Advanced Gastric Cancer
Lead Sponsor:
Japan Clinical Cancer Research Organization
Collaborating Sponsors:
Taiho Pharmaceutical Co., Ltd.
Conditions:
Gastric Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE2
PHASE3
Brief 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.
Detailed Description
Standard chemotherapy for advanced gastric cancer (AGC) in the US is Cisplatin/5-FU (CF) or docetaxel/CF (DCF), is in Europe epirubicin/CF (ECF) or epirubicin/oxaliplatin/ capecitabine (EOX). Until 20...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00639327
Start Date
March 1 2008
End Date
June 1 2011
Last Update
June 28 2011
Active Locations (86)
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1
Midori Municipal Hospital
Nagoya, Aichi-ken, Japan, 458-0037
2
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan, 467-8602
3
Aichi Medical University Hospital
Okazaki, Aichi-ken, Japan, 480-1195
4
Nakadoori General Hospital
Akita, Akita, Japan, 010-8577