Randomized Phase II/III Trial of Second Line Chemotherapy Comparing CPT-11 Monotherapy Versus S-1/CPT-11 Combination for S-1 Refractory Gastric Cancer
20 Years
N/A
Both
Gastric Cancer
Trial Information
Randomized Phase II/III Trial of Second Line Chemotherapy Comparing CPT-11 Monotherapy Versus S-1/CPT-11 Combination for S-1 Refractory Gastric Cancer
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 2006, there was no evidence of standard chemotherapy for AGC in Japan. In 2007,
by the results of JCOG9912 trial (5-FU alone vs. CPT-11/CDDP vs S-1) and SPIRITS trial (S-1
alone vs. S-1/CDDP), S-1/CDDP is regarded as a new standard regimen in Japan. In 2008, by
the results of TOP-002 trial (s-1 alone vs. S-1/CPT-11), S-1/CPT-11 could not show the
superiority to S-1 alone. One of the other phase III trials, JACCRO GC-03 trial (S-1 alone
vs. S-1/docetaxel, NCT00287768) is now ongoing. However, the position of CPT-11 in the
treatment of AGC will be regarded as a second-line.
In Japan there is a controversy for the treatment of S-1 refractory gastric cancer. The
controversy is continuing S-1 (like FOLFOX to FOLFIRI) or not as a second-line. After the
successful adjuvant S-1 results (ACTS-GC trial), the same problem will occur in the patients
who are recurrent from adjuvant S-1.
Then, we conducted a phase II/III trial of CPT-11 with or without S-1 in the treatment of
first-line S-1 refractory AGC.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
In phase II part, progressive disease rate will be measured for the safety. In phase III part, overall survival will be measured for the benefit of doublet.
Outcome Time Frame:
Phase II: 6 weeks from treatment, Phase III: 2 years OS from randomization
Safety Issue:
Yes
Principal Investigator
Masashi Fujii, M.D.,PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Surugadai Nihon University Hospital
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
JACCRO GC-05
NCT ID:
NCT00639327
Start Date:
March 2008
Completion Date:
June 2011
Related Keywords:
- Gastric Cancer
- Stomach Neoplasms
- Second line chemotherapy
- Refractory to S-1
- irinotecan
- S-1 and Irinotecan Combination
- Phase III study
- Stomach Neoplasms
Name | Location |
|---|
