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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
S-1 plus LV (The combination therapy of S-1 and Leucovorin)
Sponsored by
Taiho Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sun Yat-sen University Cancer Center, Division of Oncology
  • Shanghai Fudan University Cancer Hospital, Division of Oncology
  • PLA 307 Hospital, No.4 Division of Oncology
  • Beijing Cancer Hospital, Digestive System Medicine Department
  • Cancer Institute & Hospital Chinese Academy of Medical Sciences, Division of Oncology
  • Graduate School of Medical Sciences Kumamoto University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

S-1 plus LV

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR)

Secondary Outcome Measures

Safety
Progression free survival (PFS)
Disease control rate(DCR)
Time to treatment failure (TTF)
Overall survival (OS)
Feasibility
Pharmacokinetics

Full Information

First Posted
April 30, 2009
Last Updated
January 16, 2012
Sponsor
Taiho Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00891332
Brief Title
Study of S-1 Plus LV for Untreated Metastatic Colorectal Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiho Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
S-1 plus LV
Intervention Type
Drug
Intervention Name(s)
S-1 plus LV (The combination therapy of S-1 and Leucovorin)
Intervention Description
S-1 40-60 mg bid day 1～day 7 LV 25 mg bid day 1～day 7
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Time Frame
During chemotherapy
Secondary Outcome Measure Information:
Title
Safety
Time Frame
During chemotherapy
Title
Progression free survival (PFS)
Time Frame
Until progression
Title
Disease control rate(DCR)
Time Frame
During chemotherapy
Title
Time to treatment failure (TTF)
Time Frame
Until progression
Title
Overall survival (OS)
Time Frame
Over two years from registration
Title
Feasibility
Time Frame
During chemotherapy
Title
Pharmacokinetics
Time Frame
During chemotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hideo Baba, M.D.
Organizational Affiliation
Graduate School of Medical Sciences Kumamoto University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center, Division of Oncology
City
Dong feng Dong road,Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Shanghai Fudan University Cancer Hospital, Division of Oncology
City
Dong An Road, Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
PLA 307 Hospital, No.4 Division of Oncology
City
East Avenue, Fengtai District, Beijing
ZIP/Postal Code
100071
Country
China
Facility Name
Beijing Cancer Hospital, Digestive System Medicine Department
City
Fucheng Road, Haidian District, Beijing
ZIP/Postal Code
100036
Country
China
Facility Name
Cancer Institute & Hospital Chinese Academy of Medical Sciences, Division of Oncology
City
Panjiayuan Nanli, Chaoyang District, Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Graduate School of Medical Sciences Kumamoto University
City
1-1-1, Honjo Kumamoto-city, Kumamoto
ZIP/Postal Code
860-8556
Country
Japan

12. IPD Sharing Statement

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

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