Second Line Chemotherapy for S-1 Refractory Advanced Gastric Cancer - Full Text View

Sponsors and Collaborators:	Japan Clinical Cancer Research Organization Taiho Pharmaceutical Co., Ltd.
Information provided by:	Japan Clinical Cancer Research Organization
ClinicalTrials.gov Identifier:	NCT00639327

Purpose

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.

Condition	Intervention	Phase
Gastric Cancer	Drug: S-1 + irinotecan Drug: irinotecan	Phase II Phase III

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Irinotecan Irinotecan hydrochloride S 1 (Combination)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Japan Clinical Cancer Research Organization:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Adverse events, response rates, progression free survival, time to treatment failure, change over rates to 3rd line [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	March 2008
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental CPT-11+ S-1	Drug: S-1 + irinotecan Irinotecan 150mg/m2 iv on day one and S-1 po days 1 to 14 every 3 weeks until PD
B: Active Comparator CPT-11	Drug: irinotecan Irinotecan 150mg/m2 iv on day one every two weeks until PD

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 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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639327

Contacts

Contact: Masashi Fujii, M.D.,PhD	81-3-3293-1711 ext 207	mfujii@med.nihon-u.ac.jp
Contact: Toshifusa Nakajima, M.D.,PhD	81-3-3570-0437	nakajima@jfcr.or.jp

Locations

Japan
Aomori Prefectural Central Hospital	Not yet recruiting
Aomori, Japan, 030-8553
Principal Investigator: Sou Saito, MD
Kochi Health Sciences Center	Recruiting
Kochi, Japan, 781-8555
Principal Investigator: Akihito Tsuji, MD
Niigata Prefectural Cancer Center	Not yet recruiting
Niigata, Japan, 951-8566
Principal Investigator: Atsushi Nashimoto, MD
Japan, Aomori
Hirosahi University Graduate School of Medicine	Not yet recruiting
Hirosaki, Aomori, Japan, 036-8562
Principal Investigator: Jugoh Itoh, MD
Japan, Hokkaido
Hakodate Goryoukaku Hopsital	Not yet recruiting
Hakodate, Hokkaido, Japan, 040-0001
Principal Investigator: Akinori Takagane, MD
Japan, Kagoshima
Kirishima Medical Center	Not yet recruiting
Kirishima, Kagoshima, Japan, 899-5112
Principal Investigator: Takaharu Misaka, MD
Japan, Shiga
Saiseikai Shiga Hospital	Not yet recruiting
Ritto, Shiga, Japan, 520-3046
Principal Investigator: Tadashi Shigematsu, MD
Japan, Tokyo
Japan Clinical Cancer Research Organization	Not yet recruiting
Koto-ku, Tokyo, Japan, 135-8550
Contact: Toshifusa Nakajima, M.D.,PhD 81-3-3570-0437 nakajima@jfcr.or.jp
Contact: Masashi Fujii, M.D.,PhD 81-3-3293-1711 ext 207 mfujii@med.nihon-u.ac.jp
Surugadai Nihon University Hospital	Not yet recruiting
Chiyoda-ku, Tokyo, Japan, 101-8309
Principal Investigator: Masashi Fujii, MD
Japan, Toyama
Saiseikai Takaoka Hospital	Not yet recruiting
Takaoka, Toyama, Japan, 933-8525
Principal Investigator: Nozomu Murakami, MD

Sponsors and Collaborators

Japan Clinical Cancer Research Organization

Taiho Pharmaceutical Co., Ltd.

Investigators

Principal Investigator:

Masashi Fujii, M.D.,PhD

Surugadai Nihon University Hospital

More Information

Responsible Party:	Department of Digestive Surgery, Surugadai Nihon University Hospital ( Masashi Fujii/Associate Professor )
Study ID Numbers:	JACCRO GC-05
Study First Received:	March 5, 2008
Last Updated:	March 19, 2008
ClinicalTrials.gov Identifier:	NCT00639327
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Cancer Research Organization:

Stomach Neoplasms
Second line chemotherapy
Refractory to S-1

irinotecan
S-1 and Irinotecan Combination
Phase III study

Study placed in the following topic categories:

Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases

Stomach Neoplasms
Irinotecan
Gastrointestinal Neoplasms
Stomach cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009