Randomized Phase II Study of SOL for Untreated Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Randomized Phase II Study of S-1, Oral Leucovorin, and Oxaliplatin Combination Therapy (SOL) Versus 5-FU, l-LV and Oxaliplatin Combination Therapy (mFOLFOX6) in Patients With Untreated Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00721916
• Other study ID #: Taiho10020390
• Status: Completed
• Phase: Phase 2
• First received: July 23, 2008
• Last updated: October 31, 2012
• Start date: July 2008
• Est. completion date: May 2012

Study information

• Verified date: October 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 randomized, multicenter study designed to evaluate the progression free survival of the SOL group (S-1, Leucovorin, and Oxaliplatin) compared with the mFOLFOX6 group (5-FU, l-LV and Oxaliplatin) as first-line treatment of patients with metastatic colorectal cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: May 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Histologically proved adenocarcinoma (colorectal cancer).

• Age: 20 = at enrollment.

• 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 or Oxaliplatin containing treatment shall be excluded.

• At least one measurable lesion by RECIST criteria

Exclusion Criteria:

• Serious drug hypersensitivity.

• Prior history of peripheral neuropathy.

• Diarrhea .

• Simultaneously active double cancer.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin)
L-OHP 85 mg/m2 iv. for 2 hr on day 1 of each 2 weeks cycle S-1 40-60 mg bid day 1~day 7 LV 25 mg bid day 1~day 7
• mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin)
L-OHP 85 mg/m2 iv. for 2 hr on day 1 of each 2 weeks cycle l-LV 200 mg/m2 iv. for 2 hr on day 1 5-FU 400 mg/m2 bolus on day 1 5-FU 2400 mg/m2 ci for 46 hr (day 1, 2hr~48hr)

Locations

Country	Name	City	State
Japan	Shizuoka Cancer Center	Shimonagakubo Nagaizumi-cho Sunto-gun	Shizuoka

Sponsors (2)

Lead Sponsor	Collaborator
Taiho Pharmaceutical Co., Ltd.	Yakult Honsha Co., LTD

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS)		Until progression	No
Secondary	Safety		During chemotherapy	Yes