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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: S-1 plus LV (The combination therapy of S-1 and Leucovorin)

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Response Rate (ORR)	During chemotherapy

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression free survival (PFS)	Until progression
Safety	During chemotherapy
Disease control rate(DCR)	During chemotherapy
Time to treatment failure (TTF)	Until progression
Overall survival (OS)	Over two years from registration
Feasibility	During chemotherapy
Pharmacokinetics	During chemotherapy

Collaborators and Investigators

• Sponsor: Taiho Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Hideo Baba, M.D., Graduate School of Medical Sciences Kumamoto University

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: April 30, 2009
• First Submitted That Met QC Criteria: April 30, 2009
• First Posted (Estimate): May 1, 2009

Study Record Updates

• Last Update Posted (Estimate): January 18, 2012
• Last Update Submitted That Met QC Criteria: January 16, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Protective Agents; Micronutrients; Vitamins; Antidotes; Vitamin B Complex; Leucovorin
• Other Study ID Numbers: Taiho10020400