Randomized Phase II Study of SOL for Untreated Metastatic Colorectal Cancer

• Sponsor: Taiho Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00721916
• Collaborator: Yakult Honsha Co., LTD (Industry)
• Enrollment: 107
• Location: 1
• Arms: 2
• Duration (Months): 46
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Drug: SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin); Drug: mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin)	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 107 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin)	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
Active Comparator: 2 mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin)	Drug: 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)

Outcome Measures

Primary Outcome Measures

1. Progression free survival (PFS) [Until progression]

Secondary Outcome Measures

1. Safety [During chemotherapy]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shizuoka Cancer Center	Shimonagakubo Nagaizumi-cho Sunto-gun	Shizuoka	Japan	411-8777

Sponsors and Collaborators

• Taiho Pharmaceutical Co., Ltd.
• Yakult Honsha Co., LTD

Investigators

• Study Chair: Narikazu Boku, MD, St. Marianna University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Taiho Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT00721916
• Other Study ID Numbers: Taiho10020390
• First Posted: Jul 25, 2008
• Last Update Posted: Nov 1, 2012
• Last Verified: Oct 1, 2012

• Additional relevant MeSH terms: Colorectal Neoplasms; Leucovorin; Oxaliplatin

Study Results

No Results Posted as of Nov 1, 2012