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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00891332
First received: April 30, 2009
Last updated: January 16, 2012
Last verified: January 2012
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Taiho Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Overall Response Rate (ORR) [ Time Frame: During chemotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: During chemotherapy ] [ Designated as safety issue: Yes ]
  • Progression free survival (PFS) [ Time Frame: Until progression ] [ Designated as safety issue: No ]
  • Disease control rate(DCR) [ Time Frame: During chemotherapy ] [ Designated as safety issue: No ]
  • Time to treatment failure (TTF) [ Time Frame: Until progression ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: Over two years from registration ] [ Designated as safety issue: No ]
  • Feasibility [ Time Frame: During chemotherapy ] [ Designated as safety issue: No ]
  • Pharmacokinetics [ Time Frame: During chemotherapy ] [ Designated as safety issue: No ]

Enrollment: 73
Study Start Date: October 2008
Study Completion Date: November 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00891332

Locations
China, Guangdong
Sun Yat-sen University Cancer Center, Division of Oncology
Dong feng Dong road,Guangzhou, Guangdong, China, 510060
China
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
Japan
Graduate School of Medical Sciences Kumamoto University
1-1-1, Honjo Kumamoto-city, Kumamoto, Japan, 860-8556
Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Hideo Baba, M.D. Graduate School of Medical Sciences Kumamoto University
  More Information

No publications provided

Responsible Party: Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00891332     History of Changes
Other Study ID Numbers: Taiho10020400
Study First Received: April 30, 2009
Last Updated: January 16, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
 Intestinal Diseases
Rectal Diseases
Leucovorin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013