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Study of S-1 Plus LV for Untreated Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00891332
Recruitment Status : Completed
First Posted : May 1, 2009
Last Update Posted : January 18, 2012
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.

Brief Summary:
This is a multicenter study designed to evaluate the response rate of S-1 plus Leucovorin (1 week on and 1 week off) as first -line treatment for patients with metastatic colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: S-1 plus LV (The combination therapy of S-1 and Leucovorin) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of S-1 Plus LV (1 Week on and 1 Week Off) as First-line Treatment for Patients With Metastatic Colorectal Cancer
Study Start Date : October 2008
Primary Completion Date : July 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
S-1 plus LV
Drug: S-1 plus LV (The combination therapy of S-1 and Leucovorin)
S-1 40-60 mg bid day 1~day 7 LV 25 mg bid day 1~day 7

Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: During chemotherapy ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: During chemotherapy ]
  2. Progression free survival (PFS) [ Time Frame: Until progression ]
  3. Disease control rate(DCR) [ Time Frame: During chemotherapy ]
  4. Time to treatment failure (TTF) [ Time Frame: Until progression ]
  5. Overall survival (OS) [ Time Frame: Over two years from registration ]
  6. Feasibility [ Time Frame: During chemotherapy ]
  7. Pharmacokinetics [ Time Frame: During chemotherapy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically proved adenocarcinoma
  • Unresectable and recurrent colorectal cancer
  • Age20 ≤ at enrollment
  • Performance status 0 or 1 (ECOG)
  • No prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) to advanced disease. Patients who received adjuvant chemotherapy more than 180 days before enrollment can be allowed but those who received S-1 containing treatment shall be excluded
  • Adequate hematologic, hepatic and renal functions
  • At least one measurable lesion by RECIST criteria

Exclusion Criteria:

  • Serious drug hypersensitivity
  • Pregnant or nursing
  • Bleeding from gastrointestinal tract
  • Diarrhea
  • Simultaneously active double cancer
  • Serious illness or medical condition
  • Brain metastasis

Information from the National Library of Medicine

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): NCT00891332

China, Guangdong
Sun Yat-sen University Cancer Center, Division of Oncology
Dong feng Dong road,Guangzhou, Guangdong, China, 510060
Shanghai Fudan University Cancer Hospital, Division of Oncology
Dong An Road, Shanghai, China, 200032
PLA 307 Hospital, No.4 Division of Oncology
East Avenue, Fengtai District, Beijing, China, 100071
Beijing Cancer Hospital, Digestive System Medicine Department
Fucheng Road, Haidian District, Beijing, China, 100036
Cancer Institute & Hospital Chinese Academy of Medical Sciences, Division of Oncology
Panjiayuan Nanli, Chaoyang District, Beijing, China, 100021
Graduate School of Medical Sciences Kumamoto University
1-1-1, Honjo Kumamoto-city, Kumamoto, Japan, 860-8556
Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.
Principal Investigator: Hideo Baba, M.D. Graduate School of Medical Sciences Kumamoto University

Responsible Party: Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00891332     History of Changes
Other Study ID Numbers: Taiho10020400
First Posted: May 1, 2009    Key Record Dates
Last Update Posted: January 18, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases