Randomized Phase II Study of SOL for Untreated Metastatic Colorectal Cancer

NCT00721916 | Completed Phase 2 DMC

• 1 other identifier: Taiho10020390
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  Until progression

Secondary Outcomes (1)

• Safety

  During chemotherapy

Study Arms (2)

1

EXPERIMENTAL

SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin)

Drug: SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin)

2

ACTIVE COMPARATOR

mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin)

Drug: mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin)

Interventions

SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin) DRUG

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

1

mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin) DRUG

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)

2

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Serious drug hypersensitivity.
• Prior history of peripheral neuropathy.
• Diarrhea .
• Simultaneously active double cancer.

Sponsors & Collaborators

• Taiho Pharmaceutical Co., Ltd.: lead
• Yakult Honsha Co., LTD: collaborator

Study Sites (1)

Shizuoka Cancer Center

Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka, 411-8777, Japan

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Leucovorin; Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals

Study Officials

• Narikazu Boku, MD

  St. Marianna University School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2008
• First Posted: July 25, 2008
• Study Start: July 1, 2008
• Primary Completion: March 1, 2012
• Study Completion: May 1, 2012
• Last Updated: November 1, 2012

Record last verified: 2012-10

Locations

JP (1)