Second Line Chemotherapy for S-1 Refractory Advanced Gastric Cancer
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| ClinicalTrials.gov Identifier: NCT00639327 |
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Recruitment Status :
Completed
First Posted : March 20, 2008
Last Update Posted : June 28, 2011
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Gastric Cancer | Drug: S-1 + irinotecan Drug: irinotecan | Phase 2 Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 300 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Study Start Date : | March 2008 |
| Actual Primary Completion Date : | April 2011 |
| Actual Study Completion Date : | June 2011 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: A
CPT-11+ S-1
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Drug: S-1 + irinotecan
Irinotecan 150mg/m2 iv on day one and S-1 po days 1 to 14 every 3 weeks until PD
Other Names:
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Active Comparator: B
CPT-11
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Drug: irinotecan
Irinotecan 150mg/m2 iv on day one every two weeks until PD
Other Name: CPT-11 |
- 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. [ Time Frame: Phase II: 6 weeks from treatment, Phase III: 2 years OS from randomization ]
- Adverse events, response rates, progression free survival, time to treatment failure, change over rates to 3rd line [ Time Frame: 2 years ]
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| Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00639327
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| Principal Investigator: | Masashi Fujii, M.D.,PhD | Surugadai Nihon University Hospital |
| Responsible Party: | Masashi Fujii/Associate Professor, Department of Digestive Surgery, Surugadai Nihon University Hospital |
| ClinicalTrials.gov Identifier: | NCT00639327 |
| Other Study ID Numbers: |
JACCRO GC-05 |
| First Posted: | March 20, 2008 Key Record Dates |
| Last Update Posted: | June 28, 2011 |
| Last Verified: | June 2011 |
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Stomach Neoplasms Second line chemotherapy Refractory to S-1 |
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