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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00891332
• Other study ID #: Taiho10020400
• Status: Completed
• Phase: Phase 2
• First received: April 30, 2009
• Last updated: January 16, 2012
• Start date: October 2008
• Est. completion date: November 2011

Study information

• Verified date: January 2012
• Source: Taiho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: November 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Pharmaceutical Co., Ltd.

Countries where clinical trial is conducted

China,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR)		During chemotherapy	No
Secondary	Safety		During chemotherapy	Yes
Secondary	Progression free survival (PFS)		Until progression	No
Secondary	Disease control rate(DCR)		During chemotherapy	No
Secondary	Time to treatment failure (TTF)		Until progression	No
Secondary	Overall survival (OS)		Over two years from registration	No
Secondary	Feasibility		During chemotherapy	No
Secondary	Pharmacokinetics		During chemotherapy	No